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A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder

NCT00490971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2015-04-15

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

Conditions

Interventions

DRUG

Olanzapine

Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence

DRUG

Paliperidone ER

Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence

DRUG

Placebo

Once daily until recurrence (only after initial 15 weeks on paliperidone ER)

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
2006-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Bulgaria
  • China
  • Costa Rica
  • France
  • Germany
  • India
  • Malaysia
  • Panama
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • 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 NCT00490971 on ClinicalTrials.gov