A Study of JNJ-61393215 in the Treatment of Depression
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JNJ-61393215 135 milligram (mg) Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
Drug: JNJ-61393215
JNJ-61393215 will be administrated orally.
Other Names:
|
| Placebo Comparator: Placebo Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
Drug: Placebo
Matching placebo will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6 [Baseline and Week 6]
HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.
Secondary Outcome Measures
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6 [Baseline and Week 6]
HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the Structured Interview Guide version of the HAM-A (SIGH-A) will be used.
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Weeks 2 and 4 [Baseline, Weeks 2 and 4]
HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the SIGH-A will be used.
- Change from Baseline in HDRS-17 Total Score in Participants with a Baseline HAM-A Score Greater than or Equal to (>=) 20 at Week 6 [Baseline and Week 6]
HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.
- Change from Baseline in HAM-A Total Score in Participants with a Baseline HAM-A Score >=20 at Week 6 [Baseline and Week 6]
HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the SIGH-A will be used.
- Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6 [Baseline and Week 6]
GAD-7 is a self-administrated test to assess generalized anxiety disorder. GAD-7 has 7 items, which measure severity of various signs of GAD according to reported response categories with each item is rated on a 4-point scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety.
- Change from Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2, 4 and 6 [Baseline, Weeks 2, 4 and 6]
PHQ-9 will be used as a participant-reported measure of depressive symptomatology. The PHQ-9 is a 9-item scale, where each item is rated on a 4-point scale (0=not at all, 1=several Days, 2=more than half the days, and 3=nearly every day), with a total score range of 0 to 27. The recall period is 2 weeks.
- Change from Baseline in HDRS-17 Total Score at Weeks 2 and 4 [Baseline, Weeks 2 and 4]
HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Up to Week 12]
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Area Under the Plasma Concentration-time Curve (AUC) of JNJ-61393215 [Day 1 (Baseline), Days 15, 29 and 43]
AUC is the area under the plasma concentration-time curve observed during a dosing interval.
- Trough Plasma Concentration (Ctrough) of JNJ-61393215 [Day 1 (Baseline), Days 15, 29 and 43]
Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
- Maximum Observed Plasma Concentration (Cmax) of JNJ-61393215 [Day 1 (Baseline), Days 15, 29 and 43]
Cmax is the maximum observed plasma concentration.
- Plasma Protein Binding (PPB) of JNJ-61393215 [Week 6 (Day 43)]
Plasma protein binding (PPB) of JNJ-61393215 will be determined by using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
-
Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
-
Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
-
Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
-
Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
-
Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ
-
A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
Exclusion Criteria:
-
Participant has any other psychiatric condition including but not limited to: MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
-
Age of onset of depression is after 55 years of age
-
Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
-
Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the Colombia suicide severity rating scale (C-SSRS) at screening or baseline
-
Length of current major depressive episode >60 months
-
Participant has organic brain disease or dementia or has known or suspected intellectual development disorder
-
Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit
-
Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease
-
Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol)
-
Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval >=450 ms for males or >=470 ms for females, or >480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded
-
Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Collaborative NeuroScience Network | Garden Grove | California | United States | 92845 |
| 2 | Atlanta Institute | Alpharetta | Georgia | United States | 30022 |
| 3 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30331 |
| 4 | The Medical Research Network, LLC | New York | New York | United States | 10128 |
| 5 | Richmond Behavioural Associates | Staten Island | New York | United States | 10312 |
| 6 | Ohio State University | Columbus | Ohio | United States | 43220 |
| 7 | IPS Research Company | Oklahoma City | Oklahoma | United States | 73106 |
| 8 | Suburban Research Associates | Media | Pennsylvania | United States | 19063 |
| 9 | UT Southwestern Medical Center | Dallas | Texas | United States | 75235 |
| 10 | ARENSIA | Chisinau | Moldova, Republic of | MD2025 | |
| 11 | City Clinical Psychiatric Hopsital 3 | Moscow | Russian Federation | 107076 | |
| 12 | Nizny Novgorod clinical psychiatric hospital 1 | Nizny Novgorod | Russian Federation | 603155 | |
| 13 | Orenburg Regional Clinical Psychiatric Hospital #1 | Orenburg | Russian Federation | ||
| 14 | Medical and Rehabilitation Research Center Phoenix | Rostov-on-Don | Russian Federation | 344010 | |
| 15 | Engels psychiatric hospital | Saratov Region | Russian Federation | 413124 | |
| 16 | SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky | Saratov | Russian Federation | 410028 | |
| 17 | Saratov Regional Psychiatric hospital named after St. Sofia | Saratov | Russian Federation | 410060 | |
| 18 | Psychoneurological dispensary 10 | St-Petersburg | Russian Federation | 190121 | |
| 19 | City Psychiatric hospital 7 named after I.P.Pavlov | St-Petersburg | Russian Federation | 199034 | |
| 20 | Psychoneurological dispensary 1 | St-Petersburg | Russian Federation | 199178 | |
| 21 | Psychoneurological Dispensary #4 | St.Peterburg | Russian Federation | 197110 | |
| 22 | Stavropol Region Psychiatric Hospital #2 | Stavropol | Russian Federation | 357034 | |
| 23 | Research Institute of Mental Health | Tomsk | Russian Federation | 634014 | |
| 24 | MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association | Glevakha | Ukraine | 8630 | |
| 25 | CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC' | Ivano-Frankivsk | Ukraine | 76011 | |
| 26 | Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3' | Kharkiv | Ukraine | 61068 | |
| 27 | CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council | Kherson | Ukraine | 73488 | |
| 28 | Kyiv Railway Station Clinical Hospital #2 | Kyiv | Ukraine | 03049 | |
| 29 | Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council' | Nove, Kropyvnytskiy | Ukraine | 25491 | |
| 30 | CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council' | Smila | Ukraine | 20708 | |
| 31 | CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC' | Vinnytsia | Ukraine | 21005 | |
| 32 | MAC Clinical Research | Barnsley | United Kingdom | S75 3DL | |
| 33 | MAC Clinical Research | Liverpool | United Kingdom | L341BH | |
| 34 | Kings College London | London | United Kingdom | SE5 8AZ | |
| 35 | MAC Clinical Research | Manchester | United Kingdom | M139NQ |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108655
- 2019-001683-29
- 61393215MDD2001