Back to results40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asenapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Asenapine
Placebo
Arm Description
Asenapine
Placebo
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced an Adverse Event
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).
Number of Participants Who Discontinued Because of an Adverse Event
Participants who discontinued study medication due to adverse events.
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
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.
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00145509
Brief Title
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asenapine
Arm Type
Active Comparator
Arm Description
Asenapine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Asenapine
Other Intervention Name(s)
Org 5222
Intervention Description
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced an Adverse Event
Description
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).
Time Frame
up to 52 weeks
Title
Number of Participants Who Discontinued Because of an Adverse Event
Description
Participants who discontinued study medication due to adverse events.
Time Frame
40 weeks
Title
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
Description
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.
Time Frame
Baseline and 52 Weeks
Title
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
Description
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.
Time Frame
Baseline and 52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22198448
Citation
Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.
Results Reference
result
Learn more about this trial
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
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