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NCT02431702 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
A Phase 3 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 337
- Enrollment target
NCT02431702: Completed Phase 3 study, sponsored by Janssen Scientific Affairs.
NCT02431702 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 337 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431702, a Phase 3 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 337 participants
- Enrollment target
Study Summary
The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP \[that is oral paliperidone extended release {ER}, oral risperidone, or another OAP\]) in delaying time to treatment failure. The study will also evaluate changes in cognition, functioning, brain intracortical myelin (ICM) volume following treatment with PP compared with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.
Primary Outcome
Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treat
Interventions
- DRUG Haloperidol
- DRUG Olanzapine
- DRUG Aripiprazole
- DRUG Perphenazine
- DRUG Oral Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2015-07-08 |
| Est. Completion | 2019-11-12 |
| Phase | Phase 3 |
What the finished NCT02431702 record still lists
NCT02431702 is an interventional study that assigns participants to a tested intervention. The registered 337 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 (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Haloperidol is the first listed.
NCT02431702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431702 about?
NCT02431702 is a clinical study titled "A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform". The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP \[that is oral paliperidone extended release {ER}, oral risperidone, or another OAP\]) in delaying time to treatment failure....
What is the current status of trial NCT02431702?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 337 participants. The study started on 2015-07-08. Estimated completion is 2019-11-12.
What interventions are being tested in trial NCT02431702?
The interventions under investigation include: Haloperidol (DRUG), Olanzapine (DRUG), Aripiprazole (DRUG), Perphenazine (DRUG), Oral Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT02431702?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431702's enrollment target sits among peer trials
337 1059th of 2000 higher than 941 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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