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NCT03198078 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
NCT03198078: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03198078 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 316 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03198078, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
Study Summary
To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
Primary Outcome
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indic
Interventions
- DRUG Placebo
- DRUG Aripiprazole
- DRUG Brexpiprazole (OPC-34712)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 3 |
What the finished NCT03198078 record still lists
NCT03198078 is an interventional study that assigns participants to a tested intervention. The registered 316 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 (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03198078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03198078 about?
NCT03198078 is a clinical study titled "Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia". To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
What is the current status of trial NCT03198078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2017-06-30. Estimated completion is 2023-04-03.
What interventions are being tested in trial NCT03198078?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG), Brexpiprazole (OPC-34712) (DRUG).
Who is sponsoring clinical trial NCT03198078?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03198078's enrollment target sits among peer trials
316 1090th of 2000 higher than 909 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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