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A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

NCT00309699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2014-06-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.

Conditions

Interventions

DRUG

Placebo

Daily for 3 weeks

DRUG

Quetiapine

400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks

DRUG

Paliperidone ER

3 to 12 mg daily, flexibly dosed, for 12 weeks

Sponsors & Collaborators

  • 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
2006-04-30
Primary Completion
2007-09-30
Completion
2007-11-30

Countries

  • United States
  • Greece
  • Lithuania
  • Russia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00309699 on ClinicalTrials.gov