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COMPLETED Phase 3

A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder

NCT01193153 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 667 participants
Start Date 2010-09
Est. Completion 2013-10
Phase Phase 3

Sponsor

Janssen Scientific Affairs

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01193153

The ClinicalTrials.gov registry entry for NCT01193153 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 667 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01193153 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01193153?

The interventions under investigation include: Placebo (DRUG), paliperidone palmitate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01193153?

This trial is sponsored by Janssen Scientific Affairs, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial