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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Mood Disorders	Drug: Placebo Drug: Quetiapine Drug: Paliperidone ER	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Mental Disorders Mood Disorders Psychotic Disorders

Drug Information available for: Quetiapine Quetiapine fumarate 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 the total YMRS score from baseline to the last assessment during the acute treatment phase. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary effectiveness outcomes are the change in GAF from baseline to endpoint or the last assessment during the acute treatment phase and the change in total YMRS score from baseline to endpoint or the last assessment during the maintenance phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	493
Study Start Date:	May 2006
Study Completion Date:	November 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 003 Placebo Daily for 3 weeks	Drug: Placebo Daily for 3 weeks
Active Comparator: 002 Quetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks	Drug: Quetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
Experimental: 001 Paliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks	Drug: Paliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks

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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 3 years before the screening phase
total score of at least 20 on the YMRS at screening and at baseline
if taking mood stabilizers, antipsychotics, or antimanic drugs, must have discontinued that medication at least 3 days before baseline
women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization)
able and willing to comply with self-administration of medication, or have consistent help or support available.

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: NCT00309699

Sponsors and Collaborators

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

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & 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 Flexible Doses of Extended-Release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vieta E, Nuamah IF, Lim P, Yuen EC, Palumbo JM, Hough DW, Berwaerts J. A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Bipolar Disord. 2010 May;12(3):230-43.

Responsible Party:	Compound Development Team Leader, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00309699 History of Changes
Other Study ID Numbers:	CR010858, R076477BIM3002
Study First Received:	March 31, 2006
Last Updated:	June 1, 2011
Health Authority:	United States: Food and Drug Administration

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

Affective psychosis
mixed-state
bipolar disorder
manic disorder
manic-depressive psychosis

mania
manic state
paliperidone
paliperidone ER.

Additional relevant MeSH terms:

Bipolar Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Quetiapine
9-hydroxy-risperidone
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013