Phase 3
Completed N=459
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01451164 ↗Enrolled (actual)
459
Serious AEs
5.0%
Results posted
Oct 2019
Primary outcomePrimary: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score — -2.68; -4.59; -3.42; -3.09 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-2.68; -4.59; -3.42; -3.09; -5.07; -7.93 | — |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score. |
-0.96; -1.31; -0.70; -1.09; -1.72; -2.31 | — |
| SECONDARY Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score. |
-0.54; -0.83; -0.71; -0.59; -1.08; -1.46 | — |
| SECONDARY Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S) |
-0.13; -0.18; -0.09; -0.15; -0.26; -0.36 | — |
| SECONDARY Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6. |
3.87; 3.84; 4.01; 3.92; 3.87; 3.68 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01451164). 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.