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NCT01193153 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
A Phase 3 study of Schizoaffective Disorder, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 667
- Enrollment target
- 20
- Study locations
NCT01193153: Completed Phase 3 study of Schizoaffective Disorder, sponsored by Janssen Scientific Affairs.
NCT01193153 is a Phase 3 study of Schizoaffective Disorder that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 667 participants, above the 166-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (302% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193153, a Phase 3 study of Schizoaffective Disorder, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 667 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Primary Outcome
Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; wo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG paliperidone palmitate
Study Locations (20)
California
- - Garden Grove
- - Oakland
- - Oceanside
- - Pico Rivera
- - Riverside
- - San Diego
- - Torrance
Florida
- - Hollywood
- - Maitland
- - North Miami
- - Tampa
Georgia
- - Atlanta
- - Marietta
New York
- - Cedarhurst
- - Staten Island
Colorado
- - Denver
Illinois
- - Schamburg
Kansas
- - Wichita
Mississippi
- - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01193153 record still lists
NCT01193153 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (302% higher).
The record links to 1 condition, with Schizoaffective Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01193153 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01193153 about?
NCT01193153 is a clinical study titled "A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder". This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
What is the current status of trial NCT01193153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2010-09. Estimated completion is 2013-10.
What conditions does trial NCT01193153 study?
This clinical trial studies the following conditions: Schizoaffective Disorder.
What interventions are being tested in trial NCT01193153?
The interventions under investigation include: Placebo (DRUG), paliperidone palmitate (DRUG).
Who is sponsoring clinical trial NCT01193153?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01193153 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01193153's enrollment target sits among peer trials
667 4th of 103 higher than 100 of 103 other Schizoaffective Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizoaffective Disorder 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.
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