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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 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 198-participant average among 81 other Schizoaffective Disorder trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 7 states.

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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.

Conditions Studied

Schizoaffective Disorder Psychotic Disorder

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

FieldValue
Enrollment Target 307 participants
Start Date 2006-12
Est. Completion 2008-06
Phase Phase 3

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

102 total trials

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What the Registry Record Tells You About NCT00412373

The ClinicalTrials.gov registry entry for NCT00412373 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 198-participant average among 81 other Schizoaffective Disorder trials with a reported enrollment target (55% higher). The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.