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 - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00309686

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Mania Affective Psychosis, Bipolar	Drug: Paliperidone ER	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Psychotic Disorders

Drug Information available for: Paliperidone

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	296
Study Start Date:	April 2006
Study Completion Date:	August 2007

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309686

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

Additional Information:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR010855
Study First Received:	March 31, 2006
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00309686 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

manic disorder
bipolar disorder
manic state
paliperidone ER
mania

adjunctive therapy
paliperidone
Affective psychosis
manic-depressive psychosis

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Pharmacologic Actions

Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 30, 2009