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NCT02109562 · ClinicalTrials.gov registry record · Phase 3
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
A Phase 3 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
NCT02109562: Completed Phase 3 study, sponsored by Indivior.
NCT02109562 is a Phase 3 study that has completed, run by Indivior. The registered enrollment target is 354 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02109562, a Phase 3 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
Study 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.
Primary Outcome
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative cha
Interventions
- DRUG Placebo
- DRUG Risperidone
- DRUG RBP-7000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT02109562 record still lists
NCT02109562 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02109562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02109562 about?
NCT02109562 is a clinical study titled "Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients". 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...
What is the current status of trial NCT02109562?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2014-04. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02109562?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG), RBP-7000 (DRUG).
Who is sponsoring clinical trial NCT02109562?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02109562's enrollment target sits among peer trials
354 1026th of 2000 higher than 973 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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