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Completed

NCT Number: NCT00145509

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks

Other names: Org 5222

Placebo

Drug

Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 5, 2005
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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