40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00145509
First received: September 1, 2005
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: Asenapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Experienced an Adverse Event [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
    Participants who discontinued study medication due to adverse events.

  • Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 77
Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00145509     History of Changes
Other Study ID Numbers: P05786, A7501009
Study First Received: September 1, 2005
Results First Received: March 26, 2010
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2014