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

NCT01193153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2015-01-05

Study results available
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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

  • Schizoaffective Disorder

Interventions

DRUG

Placebo

monthly by i.m. injection for 15 months

DRUG

paliperidone palmitate

78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Bulgaria
  • India
  • Malaysia
  • Philippines
  • Romania
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193153 on ClinicalTrials.gov