Phase 3
N=239
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01397786 ↗Enrolled (actual)
239
Serious AEs
10.9%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs) — 60.2; 56.4; 65.2; 60.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-34712 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
60.2; 56.4; 65.2; 60.5; 60.0; 56.4 | — |
| SECONDARY Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score |
-6.90; -12.50; -6.60; -8.00; -11.0; -18.40 | — |
| SECONDARY Mean Change From Baseline in PANSS Positive Subscale Score |
-2.10; -4.10; -1.70; -2.40; -3.20; -5.80 | — |
| SECONDARY Mean Change From Baseline in PANSS Negative Subscale Score |
-1.40; -2.40; -1.30; -1.60; -2.70; -3.70 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score |
-0.35; -0.60; -0.24; -0.38; -0.55; -0.97 | — |
| SECONDARY Mean Change From Baseline in Personal and Social Performance Scale Total Score |
4.50; 6.50; 4.50; 4.90; 7.00; 9.60 | — |
| SECONDARY Mean Clinical Global Impression - Improvement Score |
3.00; 2.77; 3.00; 2.95; 2.66; 2.26 | — |
| SECONDARY Response Rate |
34.2; 42.6; 27.2; 34.3 | — |
| SECONDARY Discontinuation Rate for Lack of Efficacy |
3.6; 3.5; 6.3; 4.2 | — |
| SECONDARY Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score |
-0.60; -1.80; -0.70; -0.90; -1.20; -2.60 | — |
| SECONDARY Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score |
-2.60; -4.70; -2.00; -2.90; -3.90; -6.60 | — |
| SECONDARY Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score |
-1.50; -2.20; -1.70; -1.70; -2.60; -3.90 | — |
| SECONDARY Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score |
-1.70; -2.60; -1.70; -1.90; -2.90; -3.70 | — |
| SECONDARY Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score |
-0.40; -1.40; -0.60; -0.60; -0.80; -1.90 | — |
| SECONDARY Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score |
-0.70; -1.50; -0.70; -0.90; -0.90; -2.40 | — |
Summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with 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
- Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
- Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
- 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 (NCT01397786). 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.