A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

Study Overview
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Brief Summary
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To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Official Title
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A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: OPC-34712
* Drug: OPC-34712
* Drug: OPC-34712
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent Patients who are experiencing acute exacerbation of psychotic symptoms Exclusion Criteria: Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br> | Drug: OPC-34712<br>* orally administered once daily<br>|
| Experimental: Mid dose<br> | Drug: OPC-34712<br>* orally administered once daily<br>|
| Experimental: Low dose<br> | Drug: OPC-34712<br>* orally administered once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* orally administered once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). | Baseline, Weeks 1, 2, 3, 4, 5, and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. | PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | Baseline, Weeks 1, 2, 3, 4, 5, and 6 | 
| Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). | Baseline, Weeks 1, 2, 3, 4, 5, and 6 | 
| Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S) | Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. | Baseline, Weeks 1, 2, 3, 4, 5, and 6 | 
| Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. | The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. | Baseline, Weeks 1, 2, 3, 4, 5, and 6 |