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

NCT00309686 | Completed Phase 3

• 1 other identifier: CR010855
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Affective Psychosis, Bipolar; Bipolar Disorder; Mania

Keywords

Affective psychosis; bipolar disorder; manic disorder; manic-depressive psychosis; mania; manic state; paliperidone; paliperidone ER; adjunctive therapy

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness outcome is the change in total YMRS score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.

Secondary Outcomes (1)

• The secondary effectiveness outcome is the change in GAF score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.

Interventions

Paliperidone ER DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• Berwaerts J, Lane R, Nuamah IF, Lim P, Remmerie B, Hough DW. Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: a randomized, placebo-controlled study. J Affect Disord. 2011 Mar;129(1-3):252-60. doi: 10.1016/j.jad.2010.09.011. Epub 2010 Oct 13.

  PMID: 20947174 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Bipolar Disorder; Mania; Affective Disorders, Psychotic

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: April 1, 2006
• Study Completion: August 1, 2007
• Last Updated: May 18, 2011

Record last verified: 2010-03