Phase 2
N=459
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00905307 ↗Enrolled (actual)
459
Serious AEs
3.7%
Results posted
Sep 2015
Primary outcome: Primary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase) — -9.76; -18.73; -16.19; -18.25 Units on a scale — p=0.2846
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OPC-34712 (Drug); Placebo (Drug); Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase) |
-9.76; -18.73; -16.19; -18.25; -17.98; -14.40 | 0.2846 |
| SECONDARY Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase) |
-3.22; -5.97; -4.94; -5.98; -6.60; -4.82 | 0.1807 |
| SECONDARY Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase) |
-1.93; -3.61; -3.84; -3.99; -3.00; -3.17 | 0.2896 |
| SECONDARY Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase) |
4.54; 11.36; 10.67; 12.17; 10.66; 7.56 | 0.3726 |
| SECONDARY Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase) |
-0.39; -0.99; -0.87; -1.10; -1.00; -0.82 | 0.0685 |
| SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) at Week 6 |
3.66; 3.08; 3.17; 3.04; 3.04; 3.34 | 0.4008 |
| SECONDARY Response Rate at Week 6 |
40.5; 57.3; 46.7; 51.6; 60.0; 49.5 | 0.6200 |
| SECONDARY Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712 |
31; 22.5; 17.8; 16.1; 16.0; 24.2 | 0.8540 |
Summary
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by 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
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
- 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 inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00905307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.