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Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

NCT00412373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2014-05-09

Study results available
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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

  • Schizoaffective Disorder
  • Psychotic Disorder

Interventions

DRUG

Placebo

for 6 weeks

DRUG

Paliperidone ER

(3-12mg/day in 3 mg/day increments for 6 weeks)

DRUG

Paliperidone ER

(3-12mg/day in 3 mg/day increments for 6 weeks)

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • India
  • Malaysia
  • Philippines
  • Romania
  • South Korea

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 NCT00412373 on ClinicalTrials.gov