Phase 3
Completed N=636
Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Acute Schizophrenia
Source: ClinicalTrials.gov NCT01396421 ↗
Enrolled (actual)
636
Serious AEs
2.7%
Results posted
Oct 2015
Primary outcomePrimary: Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score. — -19.65; -20.73; -14.90; -12.01 Units on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score. |
-19.65; -20.73; -14.90; -12.01 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score. |
-1.20; -1.15; -0.85; -0.82 | 0.0006 sig |
| SECONDARY Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score. |
-4.38; -4.87; -2.52; -2.87; -9.51; -8.86 | 0.0644 |
| SECONDARY Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score. |
-0.16; -0.16; -0.11; -0.14; -0.46; -0.43 | 0.6553 |
| SECONDARY Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) |
12.72; 13.15; 11.84; 10.26 | 0.0557 |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score |
-6.78; -6.57; -5.46; -4.35 | 0.0010 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score |
-3.65; -4.02; -3.31; -2.24 | 0.0069 sig |
| SECONDARY Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6 |
2.94; 2.94; 3.37; 3.48 | 0.0004 sig |
| SECONDARY Response Rate at Week 6 |
46.07; 47.78; 39.08; 30.34 | 0.0032 sig |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score |
-2.75; -2.87; -1.99; -1.64 | 0.0246 sig |
| SECONDARY Discontinuation Rate for Lack of Efficacy at Week 6 |
3.93; 9.44; 8.05; 10.11 | 0.0143 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score |
-7.23; -7.37; -5.78; -4.89 | 0.0014 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score |
-4.10; -4.48; -3.66; -2.80 | 0.0155 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score |
-3.72; -3.94; -2.69; -1.97 | 0.0007 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score |
-1.90; -1.91; -1.15; -0.82 | 0.0085 sig |
| SECONDARY Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score |
-3.40; -3.70; -3.27; -3.05 | 0.3284 |
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
Data sourced from ClinicalTrials.gov (NCT01396421). 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. Informational only — not medical advice.