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

Organon and Co77 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bipolar Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: up to 52 weeks

Number of Participants Who Discontinued Because of an Adverse Event

Participants who discontinued study medication due to adverse events.

Time frame: 40 weeks

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.

Time frame: Baseline and 52 Weeks

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.

Time frame: Baseline and 52 Weeks