Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Study Details
Study Description
Brief Summary
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. |
Drug: Placebo
Matching Placebo, also in tablet form taken orally, once daily in the morning.
|
| Experimental: Armodafinil 150 mg/day Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. |
Drug: Armodafinil
Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
Other Names:
|
| Experimental: Armodafinil 200 mg/day Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
Drug: Armodafinil
Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [Day 0 (baseline), Week 8]
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Secondary Outcome Measures
- Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score [Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
- Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score [Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
- Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) [Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
- Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) [Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
- Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression [Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
- Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale [Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)]
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
- Participants With Treatment-Emergent Adverse Events (TEAE) [Day 1 to Week 9]
AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.
- Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score [Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)]
The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
- Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score [Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)]
HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
- Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score [Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)]
The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit. .
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question [Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)]
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
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Documentation that the patient has had at least 1 previous manic or mixed episode.
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The patient has had no more than 6 mood episodes in the last year.
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The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
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The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).
-
Written informed consent is obtained.
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The patient is a man or woman 18 through 65 years of age.
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The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis.
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Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
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The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
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The patient has permanent accommodations and means of being contacted by the study center.
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The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial.
Exclusion Criteria:
-
The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
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The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
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The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
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The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
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The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.
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The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies.
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The patient has any clinically significant uncontrolled medical condition, treated or untreated.
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The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.
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The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.
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The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.
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The patient is a pregnant or lactating woman.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham Psychiatry Pharmaceutical Studies, Inc | Birmingham | Alabama | United States | |
| 2 | South Coast Medical Associates/SC Clinical Trials, Inc. | Anaheim | California | United States | |
| 3 | Comprehensive NeuroScience | Cerritos | California | United States | |
| 4 | Sun Valley Behavioral Medical | Imperial | California | United States | |
| 5 | North County Clinical Research | Oceanside | California | United States | |
| 6 | CNRI Los Angeles LLC | Pico Rivera | California | United States | |
| 7 | CNRI-San Diego LLC | San Diego | California | United States | |
| 8 | Clinical Innovations Inc. | Santa Ana | California | United States | |
| 9 | Schuster Medical Research Institute | Sherman Oaks | California | United States | |
| 10 | Stanford University Medical Center | Stanford | California | United States | |
| 11 | Viking Clinical Research Center | Temecula | California | United States | |
| 12 | Comprehensive NeuroScience | Washington DC | District of Columbia | United States | |
| 13 | Scientific Clinical Research, Inc. | Aventura | Florida | United States | |
| 14 | Florida Clinical Research Center | Bradenton | Florida | United States | |
| 15 | Clinical Neuroscience Solutions Inc | Jacksonville | Florida | United States | |
| 16 | Fidelity Clinical Research | Lauderhill | Florida | United States | |
| 17 | Compass Research, LLC | Orlando | Florida | United States | |
| 18 | Stedman Clinical Trials, LLC | Tampa | Florida | United States | |
| 19 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | |
| 20 | Carman Research | Smyrna | Georgia | United States | |
| 21 | Hawaii Clinical Research Center | Honolulu | Hawaii | United States | |
| 22 | Midwest Center for Neurobehavioral Medicine | Oakbrook Terrace | Illinois | United States | |
| 23 | CNS - Comprehensive Neuro Science | Park Ridge | Illinois | United States | |
| 24 | Community Research | Crestview Hills | Kentucky | United States | |
| 25 | AccelRx Research | Fall River | Massachusetts | United States | |
| 26 | Mayo College of Medicine | Rochester | Minnesota | United States | |
| 27 | Precise Research Centers | Flowood | Mississippi | United States | |
| 28 | CRI Worldwide, LLC | Mount Laurel | New Jersey | United States | |
| 29 | Behavioral Medical Research of Brooklyn | Brooklyn | New York | United States | |
| 30 | Fieve Clinical Services, Inc. | New York | New York | United States | |
| 31 | Medical and Behavioral Health Research | New York | New York | United States | |
| 32 | Behavioral Medical Research of Staten Island | Staten Island | New York | United States | |
| 33 | Richmond Behavioral Associates | Staten Island | New York | United States | |
| 34 | North Coast Clinical Trials, Inc. | Beachwood | Ohio | United States | |
| 35 | Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | United States | |
| 36 | IPS Research Company | Oklahoma City | Oklahoma | United States | |
| 37 | Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.) | Portland | Oregon | United States | |
| 38 | Lehigh Center for Clinical Research | Allentown | Pennsylvania | United States | |
| 39 | Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | United States | |
| 40 | FutureSearch Trials of Neurology | Austin | Texas | United States | |
| 41 | Insite Clinical Research | Desoto | Texas | United States | |
| 42 | Red Oak Psychiatry Associates, P.A. | Houston | Texas | United States | |
| 43 | University Hills Clinical Research | Irving | Texas | United States | |
| 44 | Aspen Clinical Research, LLC | Orem | Utah | United States | |
| 45 | Clinical Methods | Salt Lake City | Utah | United States | |
| 46 | Alliance Research Group | Richmond | Virginia | United States | |
| 47 | B.A. Psychiatric Research Cent | Buenos Aires | Argentina | ||
| 48 | Dr. Gregorio Hugo Sorin | Buenos Aires | Argentina | ||
| 49 | INECO | Buenos Aires | Argentina | ||
| 50 | Instituto FLENI | Buenos Aires | Argentina | ||
| 51 | Sanatorio Prof. León S. Morra SA | Córdoba | Argentina | ||
| 52 | Centro de Investigación y asistencia en Psiquiatria (CIAP) | Rosario | Argentina | ||
| 53 | Neurotherapy Victoria Clinical Trials | Malvern | Victoria | Australia | |
| 54 | Northern Area Mental Health Services Northern Psychiatric R | Melbourne | Victoria | Australia | |
| 55 | District Department of Psychiatric Disorders With Stationary | Bourgas | Bulgaria | ||
| 56 | State Psychiatric Hospital - Pazardjik | Pazardjik | Bulgaria | ||
| 57 | Psychiatric clinic for women UMHAT "Dr. Georgi Stranski" | Pleven | Bulgaria | ||
| 58 | ODPZS- EOOD, Plovdiv, Bulgaria | Plovdiv | Bulgaria | ||
| 59 | MHAT Doverie | Sofia | Bulgaria | ||
| 60 | Psychiatric clinic, University Hospital "Alexandrovska" | Sofia | Bulgaria | ||
| 61 | Diagnostic Consultative Center "Tchaika" | Varna | Bulgaria | ||
| 62 | MHAT - Sveta Marina | Varna | Bulgaria | ||
| 63 | Grey Nuns Hospital | Edmonton | Alberta | Canada | |
| 64 | Dr. Alexander McIntyre, Inc. | Penticton | British Columbia | Canada | |
| 65 | Providence Care Mental Health Services | Kingston | Ontario | Canada | |
| 66 | Medical Research Associates | Mississauga | Ontario | Canada | |
| 67 | Hôpital Louis Hlafontaine | Montreal | Quebec | Canada | |
| 68 | CMP/CHS du Jura | Dole | France | ||
| 69 | Centre Hospitalier de Jonzac | Jonzac | France | ||
| 70 | Hopital Universitaire Caremeau-Batiment Polyvalent, Service | Nîmes | France | ||
| 71 | Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy | Bydgoszcz | Poland | ||
| 72 | Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM | Gdansk | Poland | ||
| 73 | Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie | Gdansk | Poland | ||
| 74 | Malopolskie Centrum Medyczne | Krakow | Poland | ||
| 75 | Cape Trial Centre | Cape Town | South Africa | ||
| 76 | Flexivest Fourteen Research Centre | Cape Town | South Africa | ||
| 77 | Knighton Surgery | Cape Town | South Africa | ||
| 78 | Vista Clinic | Centurion | South Africa | ||
| 79 | Dr Magnus & Dr Brink | Johannesburg | South Africa | ||
| 80 | Paarl Medical Centre | Paarl | South Africa | ||
| 81 | Dey Clinic | Pretoria | South Africa | ||
| 82 | Hospital del Henares | Coslada (Madrid) | Spain | ||
| 83 | Clínica Universitaria de Navarra | Pamplona | Spain | ||
| 84 | Hospital Psiquiátrico de Álava | Vitoria-Gasteiz | Spain | ||
| 85 | Hospital Santiago Apostol | Vitoria | Spain | ||
| 86 | Odessa Regional Mental Hospital #2 | s. Oleksandrivka | Odessa | Ukraine | |
| 87 | Donetsk National Medical University n.a. M. Horkyy | Donetsk | Ukraine | ||
| 88 | Public Institution "Institute of Neurology, Psychiatry and N | Kharkiv | Ukraine | ||
| 89 | Kiev City Psychoneurological Hospital N 1, CNTRP | Kiev | Ukraine | ||
| 90 | Danylo Galitsky Lviv State Medical University | Lviv | Ukraine | ||
| 91 | Odessa Regional Psychoneurology Dispensary | Odessa | Ukraine | ||
| 92 | Vinnytsa National Medical University named by M.I. Pirogov | Vinnitsa | Ukraine |
Sponsors and Collaborators
- Cephalon
Investigators
- Study Director: Sponsor's Medical Expert, Cephalon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C10953/3072
- 2009-016634-27
Study Results
Participant Flow
| Recruitment Details | Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Malta, Monaco, San Marino, and Vatican City Region 4: Rest of World |
|---|---|
| Pre-assignment Detail | Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. The 200-mg/day armodafinil treatment group was discontinued per protocol Amendment 03. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Period Title: Overall Study | |||
| STARTED | 230 | 232 | 30 |
| Safety Population | 229 | 231 | 30 |
| Full Analysis Population | 224 | 230 | 28 |
| COMPLETED | 175 | 172 | 17 |
| NOT COMPLETED | 55 | 60 | 13 |
Baseline Characteristics
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. | Total of all reporting groups |
| Overall Participants | 230 | 232 | 30 | 492 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
43.8
(10.52)
|
44.4
(11.00)
|
41.2
(12.60)
|
43.9
(10.89)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
125
54.3%
|
128
55.2%
|
20
66.7%
|
273
55.5%
|
| Male |
105
45.7%
|
104
44.8%
|
10
33.3%
|
219
44.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
18
7.8%
|
16
6.9%
|
2
6.7%
|
36
7.3%
|
| Not Hispanic or Latino |
203
88.3%
|
206
88.8%
|
28
93.3%
|
437
88.8%
|
| Unknown or Not Reported |
9
3.9%
|
10
4.3%
|
0
0%
|
19
3.9%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
0.4%
|
0
0%
|
0
0%
|
1
0.2%
|
| Asian |
3
1.3%
|
2
0.9%
|
2
6.7%
|
7
1.4%
|
| Native Hawaiian or Other Pacific Islander |
1
0.4%
|
0
0%
|
0
0%
|
1
0.2%
|
| Black or African American |
54
23.5%
|
49
21.1%
|
13
43.3%
|
116
23.6%
|
| White |
162
70.4%
|
166
71.6%
|
14
46.7%
|
342
69.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
9
3.9%
|
15
6.5%
|
1
3.3%
|
25
5.1%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
86.7
(20.21)
|
86.3
(19.21)
|
96.7
(21.91)
|
87.1
(19.96)
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
169.6
(9.88)
|
169.9
(9.44)
|
170.4
(8.25)
|
169.7
(9.57)
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
30.2
(6.86)
|
29.9
(6.39)
|
33.6
(7.58)
|
30.3
(6.73)
|
| Time Since Start of Current Depressive Episode (weeks) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [weeks] |
11.2
(7.79)
|
12.4
(8.99)
|
14.7
(8.73)
|
12.0
(8.46)
|
| Time Since First Diagnosis for Bipolar (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
11.4
(9.57)
|
11.7
(9.49)
|
13.3
(10.96)
|
11.6
(9.62)
|
Outcome Measures
| Title | Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
|---|---|
| Description | The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Time Frame | Day 0 (baseline), Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | All Armodafinil |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks. |
| Measure Participants | 224 | 230 | 258 |
| Least Squares Mean (Standard Error) [units on a scale] |
-18.8
(1.02)
|
-20.9
(1.02)
|
-20.7
(0.98)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Armodafinil 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1302 |
| Comments | All statistical tests were 2-tailed at the 0.05 level of significance. | |
| Method | mixed-model repeated measures (MMRM) | |
| Comments | Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.1 | |
| Confidence Interval |
(2-Sided) 95% -4.67 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, All Armodafinil |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1350 |
| Comments | All statistical tests were 2-tailed at the 0.05 level of significance. | |
| Method | mixed-model repeated measures (MMRM) | |
| Comments | Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.9 | |
| Confidence Interval |
(2-Sided) 95% -4.51 to 0.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score |
|---|---|
| Description | A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. |
| Time Frame | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 1 (218, 223, 27) |
5
2.2%
|
7
3%
|
22
73.3%
|
| Week 2 (209, 212, 25) |
16
7%
|
17
7.3%
|
20
66.7%
|
| Week 4 (193, 190, 22) |
28
12.2%
|
27
11.6%
|
41
136.7%
|
| Week 6 (182, 181, 18) |
36
15.7%
|
41
17.7%
|
56
186.7%
|
| Week 7 (172, 178, 14) |
40
17.4%
|
44
19%
|
57
190%
|
| Week 8 (172, 169, 17) |
47
20.4%
|
49
21.1%
|
59
196.7%
|
| Endpoint (224, 230, 28) |
39
17%
|
40
17.2%
|
39
130%
|
| Title | Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score |
|---|---|
| Description | A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. |
| Time Frame | Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 1 (218, 223, 27) |
.5
0.2%
|
1
0.4%
|
7
23.3%
|
| Week 2 (209, 212, 25) |
7
3%
|
4
1.7%
|
12
40%
|
| Week 4 (193, 190, 22) |
11
4.8%
|
8
3.4%
|
18
60%
|
| Week 6 (182, 181, 18) |
19
8.3%
|
15
6.5%
|
39
130%
|
| Week 7 (172, 178, 14) |
19
8.3%
|
17
7.3%
|
43
143.3%
|
| Week 8 (172, 169, 17) |
22
9.6%
|
23
9.9%
|
47
156.7%
|
| Endpoint (224, 230, 28) |
17
7.4%
|
18
7.8%
|
29
96.7%
|
| Title | Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) |
|---|---|
| Description | The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Time Frame | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 1 (218, 223, 27) |
-6.6
(7.59)
|
-7.2
(8.28)
|
-9.9
(12.92)
|
| Week 2 (209, 212, 25) |
-11.1
(10.72)
|
-11.8
(9.85)
|
-13.9
(11.99)
|
| Week 4 (193, 190, 22) |
-15.1
(12.14)
|
-16.7
(10.98)
|
-17.8
(12.82)
|
| Week 6 (182, 181, 18) |
-18.1
(12.60)
|
-19.1
(11.77)
|
-20.7
(12.30)
|
| Week 7 (172, 178, 14) |
-19.0
(13.38)
|
021.0
(12.12)
|
-22.8
(14.57)
|
| Week 8 (172, 169, 17) |
-20.2
(13.81)
|
-22.4
(12.63)
|
-21.8
(13.42)
|
| Endpoint (224, 230, 28) |
-17.5
(14.28)
|
-19.1
(13.55)
|
-18.6
(13.76)
|
| Title | Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) |
|---|---|
| Description | The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. |
| Time Frame | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 1 (218, 223, 27) |
-2.7
(3.05)
|
-2.9
(3.51)
|
-4.5
(5.16)
|
| Week 2 (209, 212, 25) |
-4.2
(4.02)
|
-4.5
(3.97)
|
-6.0
(4.63)
|
| Week 4 (193, 190, 22) |
-5.7
(4.68)
|
-6.5
(4.29)
|
-7.4
(4.80)
|
| Week 6 (182, 181, 18) |
-6.8
(4.87)
|
-7.5
(4.58)
|
-8.8
(5.05)
|
| Week 7 (172, 178, 14) |
-7.2
(5.13)
|
-8.1
(4.68)
|
-9.6
(5.50)
|
| Week 8 (172, 169, 17) |
-7.7
(5.42)
|
-8.6
(4.88)
|
-9.8
(5.68)
|
| Endpoint (224, 230, 28) |
-6.7
(5.51)
|
-7.4
(5.24)
|
-8.1
(5.47)
|
| Title | Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression |
|---|---|
| Description | The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. |
| Time Frame | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 1 (218, 223, 27) |
-0.2
(0.48)
|
-0.3
(0.58)
|
-0.6
(0.97)
|
| Week 2 (209, 212, 25) |
-0.6
(0.83)
|
-0.6
(0.74)
|
-0.8
(1.00)
|
| Week 4 (193, 190, 22) |
-0.9
(0.99)
|
-0.9
(0.90)
|
-1.1
(1.02)
|
| Week 6 (182, 181, 18) |
-1.1
(1.14)
|
-1.1
(1.04)
|
-1.3
(0.97)
|
| Week 7 (172, 178, 14) |
-1.3
(1.14)
|
-1.3
(1.08)
|
-1.4
(1.22)
|
| Week 8 (174, 171, 17) |
-1.4
(1.24)
|
-1.5
(1.13)
|
-1.8
(1.15)
|
| Endpoint (224, 230, 28) |
-1.2
(1.27)
|
-1.2
(1.19)
|
-1.3
(1.21)
|
| Title | Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale |
|---|---|
| Description | The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. |
| Time Frame | Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 224 | 230 | 28 |
| Week 4 (193, 190, 22) |
6.4
(8.74)
|
7.2
(10.63)
|
10.0
(9.74)
|
| Week 8 (172, 171, 17) |
10.8
(11.01)
|
11.6
(11.22)
|
13.4
(11.14)
|
| Endpoint (213, 219, 25) |
9.6
(11.44)
|
9.3
(11.85)
|
10.5
(10.60)
|
| Title | Participants With Treatment-Emergent Adverse Events (TEAE) |
|---|---|
| Description | AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis. |
| Time Frame | Day 1 to Week 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 299 | 123 | 21 |
| >=1 adverse event |
102
44.3%
|
123
53%
|
21
70%
|
| Severe adverse event |
7
3%
|
7
3%
|
1
3.3%
|
| Treatment-related adverse event |
59
25.7%
|
78
33.6%
|
16
53.3%
|
| Deaths |
0
0%
|
1
0.4%
|
0
0%
|
| Other serious adverse events |
1
0.4%
|
5
2.2%
|
2
6.7%
|
| Withdrawn from study due to adverse events |
11
4.8%
|
19
8.2%
|
2
6.7%
|
| Protocol-defined adverse events |
5
2.2%
|
3
1.3%
|
3
10%
|
| Title | Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score |
|---|---|
| Description | The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. |
| Time Frame | Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 226 | 230 | 28 |
| Mean (Standard Deviation) [units on a scale] |
-0.6
(2.76)
|
-0.5
(3.47)
|
-0.5
(2.71)
|
| Title | Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score |
|---|---|
| Description | HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. |
| Time Frame | Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 218 | 221 | 25 |
| Mean (Standard Deviation) [units on a scale] |
-4.3
(4.95)
|
-4.0
(5.50)
|
-2.6
(5.67)
|
| Title | Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score |
|---|---|
| Description | The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. |
| Time Frame | Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 217 | 219 | 25 |
| Mean (Standard Deviation) [units on a scale] |
-5.2
(6.89)
|
-6.7
(7.18)
|
-6.2
(6.93)
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
1
0.4%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit. . |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (209, 212, 25) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (193, 190, 22) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (226, 230, 28) |
0
0%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
10
4.3%
|
11
4.7%
|
2
6.7%
|
| Week 2 (209, 212, 25) |
7
3%
|
11
4.7%
|
0
0%
|
| Week 4 (193, 190, 22) |
4
1.7%
|
9
3.9%
|
0
0%
|
| Week 6 (182, 181, 18) |
6
2.6%
|
6
2.6%
|
0
0%
|
| Week 7 (172, 178, 14) |
3
1.3%
|
3
1.3%
|
0
0%
|
| Week 8 (174, 171, 17) |
3
1.3%
|
5
2.2%
|
1
3.3%
|
| Endpoint (226, 230, 28) |
7
3%
|
10
4.3%
|
2
6.7%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (218, 223, 27) |
0
0%
|
2
0.9%
|
1
3.3%
|
| Week 2 (209, 212, 25) |
0
0%
|
1
0.4%
|
0
0%
|
| Week 4 (193, 190, 22) |
1
0.4%
|
1
0.4%
|
0
0%
|
| Week 6 (182, 181, 18) |
0
0%
|
3
1.3%
|
0
0%
|
| Week 7 (172, 178, 14) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (174, 171, 17) |
0
0%
|
1
0.4%
|
0
0%
|
| Endpoint (226, 230, 28) |
2
0.9%
|
2
0.9%
|
1
3.3%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (9, 10, 1) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (6, 10, 0) |
0
0%
|
1
0.4%
|
0
0%
|
| Week 4 (4, 8, 0) |
0
0%
|
1
0.4%
|
0
0%
|
| Week 6 (5, 7, 0) |
0
0%
|
2
0.9%
|
0
0%
|
| Week 7 (3, 3, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (2, 5, 0) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (18, 21, 1) |
1
0.4%
|
2
0.9%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (9, 10, 1) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (6, 10, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (4, 8, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (5, 7, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (3, 3, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (2, 5, 0) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (18, 21, 1) |
1
0.4%
|
0
0%
|
0
0%
|
| Title | Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question |
|---|---|
| Description | The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit. |
| Time Frame | Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period. |
| Arm/Group Title | Placebo | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day |
|---|---|---|---|
| Arm/Group Description | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| Measure Participants | 229 | 231 | 30 |
| Week 1 (9, 10, 1) |
0
0%
|
0
0%
|
0
0%
|
| Week 2 (6, 10, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (4, 8, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 6 (5, 7, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 7 (3, 3, 0) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (2, 5, 0) |
0
0%
|
0
0%
|
0
0%
|
| Endpoint (18, 21, 1) |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Day 1 to Week 9 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Armodafinil 150 mg/Day | Armodafinil 200 mg/Day | Placebo | |||
| Arm/Group Description | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. | Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. | |||
All Cause Mortality |
||||||
| Armodafinil 150 mg/Day | Armodafinil 200 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Armodafinil 150 mg/Day | Armodafinil 200 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/231 (2.2%) | 2/30 (6.7%) | 1/229 (0.4%) | |||
| Cardiac disorders | ||||||
| Coronary artery disease | 1/231 (0.4%) | 1 | 0/30 (0%) | 0 | 0/229 (0%) | 0 |
| General disorders | ||||||
| Non-cardiac chest pain | 1/231 (0.4%) | 1 | 0/30 (0%) | 0 | 0/229 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Accidental overdose | 1/231 (0.4%) | 1 | 0/30 (0%) | 0 | 0/229 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| Abortion spontaneous | 0/231 (0%) | 0 | 1/30 (3.3%) | 1 | 0/229 (0%) | 0 |
| Psychiatric disorders | ||||||
| Mania | 2/231 (0.9%) | 2 | 0/30 (0%) | 0 | 0/229 (0%) | 0 |
| Psychotic disorder | 0/231 (0%) | 0 | 1/30 (3.3%) | 1 | 0/229 (0%) | 0 |
| Suicidal ideation | 0/231 (0%) | 0 | 1/30 (3.3%) | 1 | 1/229 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 1/231 (0.4%) | 1 | 0/30 (0%) | 0 | 0/229 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Armodafinil 150 mg/Day | Armodafinil 200 mg/Day | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 80/231 (34.6%) | 18/30 (60%) | 59/229 (25.8%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 11/231 (4.8%) | 11 | 5/30 (16.7%) | 8 | 13/229 (5.7%) | 16 |
| Dry mouth | 10/231 (4.3%) | 10 | 5/30 (16.7%) | 6 | 3/229 (1.3%) | 3 |
| Dyspepsia | 0/231 (0%) | 0 | 2/30 (6.7%) | 2 | 0/229 (0%) | 0 |
| Nausea | 17/231 (7.4%) | 18 | 4/30 (13.3%) | 5 | 5/229 (2.2%) | 5 |
| Toothache | 2/231 (0.9%) | 2 | 2/30 (6.7%) | 3 | 0/229 (0%) | 0 |
| Infections and infestations | ||||||
| Nasopharyngitis | 7/231 (3%) | 7 | 2/30 (6.7%) | 2 | 4/229 (1.7%) | 4 |
| Nervous system disorders | ||||||
| Dizziness | 7/231 (3%) | 9 | 3/30 (10%) | 3 | 2/229 (0.9%) | 2 |
| Headache | 38/231 (16.5%) | 45 | 4/30 (13.3%) | 5 | 30/229 (13.1%) | 39 |
| Psychiatric disorders | ||||||
| Anxiety | 6/231 (2.6%) | 6 | 2/30 (6.7%) | 2 | 6/229 (2.6%) | 6 |
| Insomnia | 12/231 (5.2%) | 12 | 4/30 (13.3%) | 5 | 8/229 (3.5%) | 8 |
| Suicidal ideation | 1/231 (0.4%) | 1 | 3/30 (10%) | 3 | 2/229 (0.9%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 0/231 (0%) | 0 | 3/30 (10%) | 4 | 2/229 (0.9%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
| Name/Title | Director, Clinical Research |
|---|---|
| Organization | Teva Branded Pharmaceutical Products, R&D Inc. |
| Phone | 215-591-3000 |
| ustevatrials@tevapharm.com |
- C10953/3072
- 2009-016634-27