Phase 3
N=674
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
Acute Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01393613 ↗Enrolled (actual)
674
Serious AEs
3.1%
Results posted
Nov 2015
Primary outcome: Primary: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score. — -3.32; -4.35; -5.58; -3.48 Units on a scale — p=0.0093
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-34712 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score. |
-3.32; -4.35; -5.58; -3.48; -7.61; -8.70 | 0.0093 sig |
| SECONDARY Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score. |
-0.11; -0.16; -0.22; -0.12; -0.31; -0.40 | 0.0069 sig |
| SECONDARY Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score. |
6.97; 6.85; 7.12; 5.80; 11.73; 10.52 | 0.0005 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. |
-0.93; -1.43; -1.80; -1.25; -2.54; -2.76 | 0.0166 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. |
-0.31; -0.52; -0.88; -0.40; -1.27; -1.31 | 0.0231 sig |
| SECONDARY Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. |
3.20; 3.17; 2.95; 3.48 | 0.0009 sig |
| SECONDARY Percentage of Participants With Response at Week 6. |
43.6; 38.5; 49.7; 31.7 | 0.0006 sig |
| SECONDARY Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6. |
7.69; 11.2; 8.84; 11.7 | 0.5202 |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score. |
-0.35; -0.46; -1.01; -0.48; -0.76; -1.31 | 0.0029 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score. |
-1.44; -1.77; -1.75; -1.30; -2.97; -3.10 | 0.1273 |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score. |
-0.70; -0.85; -1.12; -0.66; -1.71; -1.86 | 0.0194 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score. |
-0.40; -0.46; -0.78; -0.42; -1.42; -1.15 | 0.0045 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score. |
0.03; -0.10; -0.63; -0.21; -0.15; -0.65 | 0.0021 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score. |
-1.18; -1.10; -1.26; -0.96; -1.86; -1.91 | 0.0104 sig |
Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
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
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01393613). 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.