Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01157351 · ClinicalTrials.gov registry record · Phase 4
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
A Phase 4 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 450
- Enrollment target
NCT01157351: Completed Phase 4 study, sponsored by Janssen Scientific Affairs.
NCT01157351 is a Phase 4 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 450 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01157351, a Phase 4 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 450 participants
- Enrollment target
Study Summary
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
Primary Outcome
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services
Interventions
- DRUG risperidone
- DRUG aripiprazole
- DRUG paliperidone
- DRUG haloperidole
- DRUG perphenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT01157351 record still lists
NCT01157351 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which risperidone is the first listed.
NCT01157351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01157351 about?
NCT01157351 is a clinical study titled "15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated". The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
What is the current status of trial NCT01157351?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 450 participants. The study started on 2010-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01157351?
The interventions under investigation include: risperidone (DRUG), aripiprazole (DRUG), paliperidone (DRUG), haloperidole (DRUG), perphenazine (DRUG).
Who is sponsoring clinical trial NCT01157351?
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 NCT01157351's enrollment target sits among peer trials
450 187th of 2000 higher than 1,813 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00515060 · 450 participants
Psychophysical Studies of Cancer Therapy Pain
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
- NCT03047161 · 450 participants
Electrophysiology of Fetal Arrhythmia
- NCT03269630 · 450 participants
New Orleans Pulmonary Hypertension Biobank
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia