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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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ClinicalTrials.gov Identifier: NCT00145509
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : April 16, 2010
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Asenapine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007


Arm Intervention/treatment
Active Comparator: Asenapine
Asenapine
Drug: Asenapine
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Other Name: Org 5222

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks




Primary Outcome Measures :
  1. 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).

  2. Number of Participants Who Discontinued Because of an Adverse Event [ Time Frame: 40 weeks ]
    Participants who discontinued study medication due to adverse events.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Publications of Results:
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00145509    
Other Study ID Numbers: P05786
A7501009
First Posted: September 5, 2005    Key Record Dates
Results First Posted: April 16, 2010
Last Update Posted: February 8, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs