- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00145509
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
February 4, 2022 updated by: Organon and Co
A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470).
The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
Study Overview
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial
Exclusion Criteria:
- Have an unstable medical condition or clinically significant laboratory abnormality.
- Have a primary diagnosis other than bipolar I disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
|
Active Comparator: Asenapine
|
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced an Adverse Event
Time Frame: up to 52 weeks
|
Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).
|
up to 52 weeks
|
Number of Participants Who Discontinued Because of an Adverse Event
Time Frame: 40 weeks
|
Participants who discontinued study medication due to adverse events.
|
40 weeks
|
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
Time Frame: Baseline and 52 Weeks
|
The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania.
Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
|
Baseline and 52 Weeks
|
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
Time Frame: Baseline and 52 Weeks
|
The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression.
MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.
|
Baseline and 52 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05786
- A7501009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
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Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
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