A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Study Details
Study Description
Brief Summary
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lurasidone Lurasidone 40 - 80mg flexible dose |
Drug: Lurasidone
Lurasidone 40-80 mg taken orally taken once daily
|
Outcome Measures
Primary Outcome Measures
- Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) [12 weeks]
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
- Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score [Baseline to week 12 LOCF endpoint]
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
- Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score. [Baseline to week 12 LOCF endpoint]
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Secondary Outcome Measures
- Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score [Baseline to week 12 LOCF endpoint]
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
- Short Form-12 Health Survey (SF-12) [Baseline to week 12 LOCF endpoint]
The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
- Modified Specific Levels of Functioning (SLOF) Total Score. [12 weeks]
The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
- Brief Adherence Rating Scale (BARS) [12 weeks]
The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
- Smoking Questionnaire [12 weeks]
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
- Intent to Attend Assessment [12 weeks]
The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?"
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has agreed to participate by providing written informed consent.
-
Subject will be eligible to participate if one of the following criteria is met:
-
Subject has completed the 28-week double-blind phase of study D1050238
-
Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
-
Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
-
Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
-
Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion Criteria:
-
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
-
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
-
Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | K and S Professional Research Services | Little Rock | Arkansas | United States | 72201 |
2 | Woodland International Research Inc. | Little Rock | Arkansas | United States | 72211 |
3 | Comprehensive Clinical Development Inc. | Cerritos | California | United States | 90703 |
4 | Diligent Clinical Trials | Downey | California | United States | 90241 |
5 | Synergy Clinical Research Center | Escondido | California | United States | 92025 |
6 | CNS Network | Garden Grove | California | United States | 92845 |
7 | AXIS Clinical Trials | Los Angeles | California | United States | 90036 |
8 | Synergy Clinical Research Center | National City | California | United States | 91950 |
9 | Excell Research, Inc. | Oceanside | California | United States | 92056 |
10 | CNRI-Los Angeles. LLC | Pico Rivera | California | United States | 90660 |
11 | California Neuropsychopharmacolgoy Clinical Research Insitute | San Diego | California | United States | 92126 |
12 | Neuropsychiatric Research Center of Orange County | Santa Ana | California | United States | 92701 |
13 | Collaborative Neuroscience Network | Torrance | California | United States | 90502 |
14 | Florida Clinical Research Center, LLC | Bradenton | Florida | United States | 34208 |
15 | Accurate Clinical Trials | Kissimmee | Florida | United States | 34742 |
16 | Galiz Research | Miami Springs | Florida | United States | 33166 |
17 | Medical Research Group of Central Florida | Orange City | Florida | United States | 32763 |
18 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30308 |
19 | Comprehensive NeuroScience Inc. | Atlanta | Georgia | United States | 30328 |
20 | Lake Charles Clinical Trials, LLC | Lake Charles | Louisiana | United States | 70601 |
21 | Lousiana Clinical Research, LLC | Shreveport | Louisiana | United States | 71104 |
22 | Center for Behavioral Health, LLC | Rockville | Maryland | United States | 20850 |
23 | Psychiatric Care and Research Center | O'Fallon | Missouri | United States | 63368 |
24 | Psych Care Consultants Research | Saint Louis | Missouri | United States | 63128 |
25 | Robert Lynn Horne, MD | Las Vegas | Nevada | United States | 89102 |
26 | CRI Worldwide LLC | Willingboro | New Jersey | United States | 08046 |
27 | Erie County Medical Center, Corp | Buffalo | New York | United States | 14215 |
28 | Neurobehavioral Research Inc. | Cedarhurst | New York | United States | 11516 |
29 | Comprehensive Clinical Development, Inc | Fresh Meadows | New York | United States | 11366 |
30 | Finger Lakes Clinical Research | Rochester | New York | United States | 14618 |
31 | Oklahoma Clinical Research | Oklahoma City | Oklahoma | United States | 73116 |
32 | CRI Worldwide LLC at Kirkbride | Philadelphia | Pennsylvania | United States | 19139 |
33 | Lincoln Research | Lincoln | Rhode Island | United States | 02865 |
34 | Community Clinical Research, Inc. | Austin | Texas | United States | 78754 |
35 | FutureSearch Clinical Trials LP | Austin | Texas | United States | 78756 |
36 | FutureSearch Clinical Trials, LP | Dallas | Texas | United States | 75231 |
37 | Pillar Clinical Research, LLC | Dallas | Texas | United States | 75243 |
38 | Department of Psychiatry, University of Utah Health Sciences Center | Salt Lake City | Utah | United States | 84132 |
39 | Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP) | Dole | France | 39100 | |
40 | Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS) | Toulon | France | 83000 | |
41 | Dipartimento Salute Mentale ASL 1 | Massa | Italy | 54100 | |
42 | A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4 | Pisa | Italy | 56100 | |
43 | Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital' | Lipetsk | Russian Federation | 398007 | |
44 | Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix' | Rostov-on-Don | Russian Federation | 344000 | |
45 | St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6" | St. Peterburg | Russian Federation | 191167 | |
46 | St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7") | St. Petersburg | Russian Federation | 190005 | |
47 | St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1 | St. Petersburg | Russian Federation | 19005 | |
48 | St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor) | St. Petersburg | Russian Federation | 191119 | |
49 | Military Medical Academy, Clnic for Psychiatry | Belgrade | Serbia | 11000 | |
50 | Institute of Mental Health | Dusica | Serbia | 11000 | |
51 | Clinical Centre Kragujevac, Clinic for psychiatry | Kragujevac | Serbia | 34000 | |
52 | Clinical Centre Nis, Clinic for mental health protection | Nis | Serbia | 18000 | |
53 | Specialized hospital for psychiatric diseases "Sveti Vracevi" | Novi Knezevac | Serbia | 23330 | |
54 | Clinical Centre Vojvodine, Clinic for Psychiatry | Novi Sad | Serbia | 21000 | |
55 | Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie | Bojnice | Slovakia | 972 01 | |
56 | Psychiatricka ambulancia Mentum s.r.o. | Bratislava | Slovakia | 82007 | |
57 | Psychiatricka nemocnica Michalovce n.o. | Michalovce | Slovakia | 071 01 | |
58 | PsychoLine s.r.o. Psychiatricka ambulancia | Rimavska Sobota | Slovakia | 97901 | |
59 | Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie | Roznava | Slovakia | 048 01 | |
60 | "Centrum zdravia R.B.K., spol. s.r.o. | Svidnik | Slovakia | 089 01 | |
61 | Cape Trial Centre | Tygervalley | Western Cape | South Africa | 7530 |
62 | Research Unit, Department of Psychiatry Free State Psychiatric Complex | Bloemfontein | South Africa | 9300 | |
63 | Denmar Hospital Consulting Rooms | Pretoria | South Africa | 0081 |
Sponsors and Collaborators
- Sunovion
Investigators
- Study Director: Lurasidone Medical Director, MD, Sunovion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1050307
- 2011-004790-90
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Period Title: Overall Study | |
STARTED | 191 |
COMPLETED | 155 |
NOT COMPLETED | 36 |
Baseline Characteristics
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Overall Participants | 191 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
42.7
(12.30)
|
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
190
99.5%
|
>=65 years |
1
0.5%
|
Sex: Female, Male (Count of Participants) | |
Female |
76
39.8%
|
Male |
115
60.2%
|
Region of Enrollment (participants) [Number] | |
Serbia |
22
11.5%
|
France |
4
2.1%
|
United States |
114
59.7%
|
Slovakia |
15
7.9%
|
Russia |
19
9.9%
|
South Africa |
17
8.9%
|
Outcome Measures
Title | Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs) |
---|---|
Description | Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs) |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 191 |
Subjects with TEAEs |
72
37.7%
|
TEASs leading to discontinuation |
7
3.7%
|
Subjects with TESAEs |
13
6.8%
|
Title | Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score |
---|---|
Description | The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. |
Time Frame | Baseline to week 12 LOCF endpoint |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 191 |
Mean (Standard Deviation) [units on a scale] |
-8.4
(15.06)
|
Title | Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score. |
---|---|
Description | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. |
Time Frame | Baseline to week 12 LOCF endpoint |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 191 |
Mean (Standard Deviation) [units on a scale] |
-0.48
(1.051)
|
Title | Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score |
---|---|
Description | The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. |
Time Frame | Baseline to week 12 LOCF endpoint |
Outcome Measure Data
Analysis Population Description |
---|
Only 182 subjects had post-baseline MADRS assessments. |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 182 |
Mean (Standard Deviation) [units on a scale] |
-3.3
(7.83)
|
Title | Short Form-12 Health Survey (SF-12) |
---|---|
Description | The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
Time Frame | Baseline to week 12 LOCF endpoint |
Outcome Measure Data
Analysis Population Description |
---|
Only 182 subjects had post-baseline SF-12.v2 assessments. |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 182 |
Mean (Standard Deviation) [units on a scale] |
-0.45
(6.642)
|
Title | Modified Specific Levels of Functioning (SLOF) Total Score. |
---|---|
Description | The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition. |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Only 174 subjects had SLOF assessments at week 12 LOCF. |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 174 |
Mean (Standard Deviation) [units on a scale] |
-1.8
(9.55)
|
Title | Brief Adherence Rating Scale (BARS) |
---|---|
Description | The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month. |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 182 |
Mean (Standard Deviation) [percentage of monthly doses taken] |
99.0
(3.08)
|
Title | Smoking Questionnaire |
---|---|
Description | Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF). |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Only 36 subjects who were smokers had the smoker questionnaire assessments. |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 36 |
Mean (Standard Deviation) [number of cigarettes smoked daily] |
11.1
(9.95)
|
Title | Intent to Attend Assessment |
---|---|
Description | The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = "Not at all" and 9 = "Extremely". The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: "How likely is it that you will complete the study?" |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Only 1825 subjects answered the questionnaire. |
Arm/Group Title | Lurasidone |
---|---|
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily |
Measure Participants | 185 |
Mean (Standard Deviation) [units on a scale] |
8.3
(1.14)
|
Adverse Events
Time Frame | 12 Weeks | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Lurasidone | |
Arm/Group Description | Lurasidone 40 - 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily | |
All Cause Mortality |
||
Lurasidone | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Lurasidone | ||
Affected / at Risk (%) | # Events | |
Total | 13/191 (6.8%) | |
Cardiac disorders | ||
Artrial flutter | 1/191 (0.5%) | 1 |
General disorders | ||
Chest Pain | 1/191 (0.5%) | 1 |
Infections and infestations | ||
Pneumonia | 1/191 (0.5%) | 1 |
Psychiatric disorders | ||
Schizophrenia | 6/191 (3.1%) | 6 |
Psychotic Disorder | 4/191 (2.1%) | 5 |
Vascular disorders | ||
Hypotension | 1/191 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Lurasidone | ||
Affected / at Risk (%) | # Events | |
Total | 34/191 (17.8%) | |
Gastrointestinal disorders | ||
Diarrhoea | 4/191 (2.1%) | 4 |
Nausea | 4/191 (2.1%) | 5 |
Infections and infestations | ||
Nasopharyngitis | 5/191 (2.6%) | 5 |
Nervous system disorders | ||
Akathisia | 10/191 (5.2%) | 10 |
Headache | 4/191 (2.1%) | 5 |
Psychiatric disorders | ||
Schizophrenia | 8/191 (4.2%) | 8 |
Anxiety | 4/191 (2.1%) | 9 |
Insomnia | 4/191 (2.1%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.
Results Point of Contact
Name/Title | Medical Director CNS Clinical Trials |
---|---|
Organization | Sunovion |
Phone | 1-866-503-6351 |
clinicaltrialdisclosure@sunvion.com |
- D1050307
- 2011-004790-90