A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- OPC-34712 [Brexpiprazole] High Dose
- Conditions
- Acute Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 636
- Primary Endpoint
- Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
Detailed Description
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
- •Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- •Subjects experiencing an acute exacerbation of psychotic symptoms
- •Other protocol specific inclusion criteria may apply
Exclusion Criteria
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- •Subjects with a current DSM-IV-TR Axis I diagnosis of:
- •Schizoaffective disorder
- •Major depressive disorder (MDD)
- •Bipolar disorder
- •Delirium, dementia, amnestic or other cognitive disorder
- •Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
- •Subjects presenting with a first episode of schizophrenia
- •Other protocol specific exclusion criteria may apply
Arms & Interventions
OPC-34712 [Brexpiprazole] High Dose
Higher Dose, tablet, once daily, for six weeks
Intervention: OPC-34712 [Brexpiprazole] High Dose
Placebo
Placebo, once daily, for six weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.
Time Frame: Baseline to Week 6
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Secondary Outcomes
- Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.(Baseline to Week 6)
- Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.(Baseline to Week 1, 2, 3, 4, 5)
- Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.(Baseline to Week 1, 2, 3, 4 and 5)
- Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)(Baseline to Week 6)
- Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score(Baseline to Week 6)
- Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score(Baseline to Week 6)
- Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6(Week 6)
- Response Rate at Week 6(Week 6)
- Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score(Baseline to Week 6)
- Discontinuation Rate for Lack of Efficacy at Week 6(Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score(Baseline to Week 6)