Phase 3
Completed N=354
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Source: ClinicalTrials.gov NCT02109562 ↗Enrolled (actual)
354
Serious AEs
0.6%
Results posted
Oct 2018
Primary outcomePrimary: Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score — -15.367; -16.456; -9.219 units on a scale — p=0.0004
◆ Published Evidence
Emerging
11citations · ~2 / year
PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients.
Summary
The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.
This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.
Linked Publications (3)
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PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients.
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Prazosin for Alcohol Use Disorder: Reply to Sinha.
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Prazosin for Alcohol Use Disorder: A Clarification.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score |
-15.367; -16.456; -9.219 | 0.0004 sig |
| SECONDARY Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S) |
-0.868; -0.914; -0.518 | 0.0002 sig |
| SECONDARY Summary of Participants With Treatment-Emergent Adverse Events (TEAE) |
34; 26; 37; 81; 91; 81 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females between the ages of 18 to 55 years, inclusive
- Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
- Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and Rule (SAFER) interview
- Subjects who are otherwise healthy on the basis of their physical examination
Exclusion Criteria
- Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment.
- Subjects taking daily oral risperidone at a dose ≥ 6 mg/day
- Subjects who have received a depot antipsychotic within 120 days of screen
- Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.
Data sourced from ClinicalTrials.gov (NCT02109562) and the linked publication. 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.