A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)

• History of at least 1 previously documented manic or mixed episode requiring medical treatment within the past 3 years

• Must have been taking lithium or valproate as part of treatment for Bipolar I Disorder for at least 2 weeks before screening, with drug levels at screening within therapeutic range

• Total YMRS score of at least 20 at screening and at baseline (Day 1)

• Women must be postmenopausal for at least 2 years or agree to practice an effective method of birth control throughout the study.

Exclusion Criteria:

• Meets DSM-IV criteria for rapid cycling and schizoaffective disorder

• In the opinion of the study doctor, is at significant risk for suicidal or violent behavior during the course of the study

• Has used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid (excluding codeine), hallucinogen, or any other drug that may be associated with manic symptoms as evidenced by a positive urine drug screen

• Has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a period of 3 months or longer immediately before the screening phase.