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NCT00946985 · ClinicalTrials.gov registry record · Phase 4

28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

A Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.

Terminated
Registry status
Phase 4
Development phase
163
Enrollment target

NCT00946985: Clinical Trial Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.

NCT00946985 is a Phase 4 study that was terminated before completion, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 163 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00946985, a Phase 4 study, was terminated before completion, sponsored by Ortho-McNeil Janssen Scientific Affairs.

TERMINATED
Registry status
Phase 4
Development phase
163 participants
Enrollment target

Study Summary

The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Primary Outcome

Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.

Interventions

  • DRUG paliperidone palmitate
  • DRUG oral risperidone

Trial Details

FieldValue
Enrollment Target 163 participants
Start Date 2009-06
Est. Completion 2010-03
Phase Phase 4

Why NCT00946985 stopped before completion

NCT00946985 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (69% lower).

The record links to 0 conditions, and to 2 interventions - of which paliperidone palmitate is the first listed.

NCT00946985 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00946985 about?

NCT00946985 is a clinical study titled "28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years". The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

What is the current status of trial NCT00946985?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 163 participants. The study started on 2009-06. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00946985?

The interventions under investigation include: paliperidone palmitate (DRUG), oral risperidone (DRUG).

Who is sponsoring clinical trial NCT00946985?

This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00946985's enrollment target sits among peer trials

163 501st of 2000 higher than 1,498 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

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Source: ClinicalTrials.gov NCT00946985, the US trial registry maintained by the National Library of Medicine. NCT00946985 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.