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NCT00412373 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
A Phase 3 study of Schizoaffective Disorder and Psychotic Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
- 20
- Study locations
NCT00412373: Completed Phase 3 study of Schizoaffective Disorder and Psychotic Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00412373 is a Phase 3 study of Schizoaffective Disorder and Psychotic Disorder that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 307 participants, above the 169-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (82% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412373, a Phase 3 study of Schizoaffective Disorder and Psychotic Disorder, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.
Primary Outcome
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, 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 consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Paliperidone ER
Study Locations (20)
California
- - Cerritos
- - Costa Mesa
- - Garden Grove
- - Huntington Beach
- - Pico Rivera
- - San Diego
Other
- - Ahmedabad
- - Ahmedibad
- - Aurangabad
- - Chennai
- - Delhi
Florida
- - Aventura
- - Hollywood
- - Kissimmee
- - Leesburg
Texas
- - Austin
- - Irving
Oklahoma
- - Oklahoma City
Pennsylvania
- - Philadelphia
South Carolina
- - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00412373 record still lists
NCT00412373 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (82% higher).
The record links to 2 conditions, with Schizoaffective Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00412373 names 20 study sites across 7 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT00412373 about?
NCT00412373 is a clinical study titled "Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.". The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.
What is the current status of trial NCT00412373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2006-12. Estimated completion is 2008-06.
What conditions does trial NCT00412373 study?
This clinical trial studies the following conditions: Schizoaffective Disorder, Psychotic Disorder.
What interventions are being tested in trial NCT00412373?
The interventions under investigation include: Placebo (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00412373?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00412373 being conducted?
This trial has 20 study locations across California, Florida, Oklahoma, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00412373's enrollment target sits among peer trials
307 11th of 103 higher than 93 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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