A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder
2 other identifiers
interventional
768
16 countries
78
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2006
Typical duration for phase_3
78 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
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
March 5, 2012
CompletedApril 15, 2015
March 1, 2015
3.9 years
June 18, 2007
April 26, 2011
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder
Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.
Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.
Secondary Outcomes (2)
Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder
Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.
Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder
Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.
Other Outcomes (4)
Young Mania Rating Scale (YMRS): Change From Baseline
From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).
Montgomery-Asberg Depression Rating Scale (MADRS)
From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).
Global Assessment of Functioning (GAF): Change From Baseline
From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).
- +1 more other outcomes
Study Arms (3)
Paliperidone ER
EXPERIMENTALPlacebo
PLACEBO COMPARATOROlanzapine
ACTIVE COMPARATORInterventions
Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence
Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence
Eligibility Criteria
You may qualify if:
- Meet DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria for Bipolar I Disorder Most Recent Episode Manic or Mixed (with or without psychotic features)
- have a history of at least 2 previously documented mood episodes associated with Bipolar I Disorder (1 of which must be a manic or mixed episode) that required medical treatment within the past 3 years
- a total score of at least 20 on the YMRS at screening and at Day 1 of the study.
You may not qualify if:
- Meet DSM-IV criteria for any type of episode associated with bipolar disorder other than Bipolar I Disorder Most Recent Episode Manic or Mixed
- Meet DSM-IV criteria for rapid cycling
- Meet DSM-IV criteria for schizoaffective disorder
- Known or suspected borderline or antisocial personality disorder
- be, in the opinion of the investigator, at significant immediate risk for suicidal or violent behavior during the course of the study based on current status or prior history (e.g., suicide attempts during previous episodes).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
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Scottsdale, Arizona, United States
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Riverside, California, United States
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San Diego, California, United States
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Jacksonville, Florida, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Willingboro, New Jersey, United States
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Cincinnati, Ohio, United States
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Lyndhurst, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Bellevue, Washington, United States
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Bulgaria, Bulgaria
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Radnevo, Bulgaria
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Sofia, Bulgaria
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Baoding, China
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Beijing, China
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Guangzhou, China
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Nanjing, China
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Shanghai, China
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Suzhou, China
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Xi'an, China
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San José, Costa Rica
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Casablanca, France
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Manouba, France
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Berlin, Germany
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Bochum, Germany
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Chemnitz, Germany
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Düsseldorf, Germany
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Göttingen, Germany
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Jena, Germany
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Lübeck, Germany
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Bangalore, India
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Calicut, India
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Coimbatore, India
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Hyderabad, India
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Ludhiana, India
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Pune, India
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Varanasi, India
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Kuala Lumpur, Malaysia
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Panama City, Panama
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Panama Panama, Panama
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Gdansk, Poland
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Krakow, Poland
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Leszno, Poland
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Skąpe, Poland
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Swiecie Poland, Poland
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Torun, Poland
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Tuszyn, Poland
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Bucharest, Romania
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Craiova, Romania
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Iași, Romania
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Tg Mures, Romania
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Timișoara, Romania
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Krasnodar, Russia
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Nizny Novgorod, Russia
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Perm, Russia
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Smolensk Region N/A, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Gornja Toponica, Serbia
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Kragujevac, Serbia
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Novi Kneževac, Serbia
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Cape Town, South Africa
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Durban Kn, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Ankara, Turkey (Türkiye)
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Manisa, Turkey (Türkiye)
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Vinnitsa, Ukraine
Related Publications (1)
Berwaerts J, Melkote R, Nuamah I, Lim P. A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. J Affect Disord. 2012 May;138(3):247-58. doi: 10.1016/j.jad.2012.01.047. Epub 2012 Feb 27.
PMID: 22377512DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study employed a randomized withdrawal design, and as such, was enriched for responders to the study drug. Thus, the long-term efficacy demonstrated cannot be extrapolated to a population of patients without prior exposure to paliperidone ER.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
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
June 18, 2007
First Posted
June 25, 2007
Study Start
May 1, 2006
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 15, 2015
Results First Posted
March 5, 2012
Record last verified: 2015-03