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
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
2 other identifiers
interventional
493
8 countries
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2006
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedJune 20, 2014
June 1, 2014
1.4 years
March 31, 2006
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary effectiveness outcome is the change in the total YMRS score from baseline to the last assessment during the acute treatment phase.
3 weeks
Secondary Outcomes (1)
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.
12 weeks
Study Arms (3)
003
PLACEBO COMPARATORPlacebo Daily for 3 weeks
002
ACTIVE COMPARATORQuetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
001
EXPERIMENTALPaliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks
Interventions
Eligibility Criteria
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 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Cerritos, California, United States
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Garden Grove, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
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Kissimmee, Florida, United States
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Maitland, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Prairie Village, Kansas, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Flowood, Mississippi, United States
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Clementon, New Jersey, United States
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Moore, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Athens, Greece
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Alytus, Lithuania
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Vilnius, Lithuania
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Kazan', Russia
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Lipetsk, Russia
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Moscow Region, Russia
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Moscow Russia, Russia
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Nizny Novgorod, Russia
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Saratov, Russia
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St-Petersburg Na, Russia
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Incheon, South Korea
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Seoul, South Korea
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Donetsk, Ukraine
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Hlevakha, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
Unknown Facility
Simferopol, Ukraine
Related Publications (1)
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. doi: 10.1111/j.1399-5618.2010.00815.x.
PMID: 20565430DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
April 1, 2006
Primary Completion
September 1, 2007
Study Completion
November 1, 2007
Last Updated
June 20, 2014
Record last verified: 2014-06