Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

Bipolar 1 Disorder Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

Status Completed

Clinical Trial Summary

This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar 1 Disorder

Clinical Trial Details

NCT number	NCT01396291
Study type	Interventional
Source	Forest Laboratories
Contact
Status	Completed
Phase	Phase 3
Start date	December 2011
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400785` - Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning	N/A
Withdrawn	`NCT01981811` - Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder	Phase 2
Recruiting	`NCT04580134` - CLOZAPINE Response in Biotype-1	Phase 4
Terminated	`NCT03643159` - A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder	Phase 4
Completed	`NCT02050854` - Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia	N/A
Completed	`NCT03386851` - Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Terminated	`NCT01674010` - Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder	Phase 2
Completed	`NCT00764478` - Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)	Phase 3