Asenapine bipolar 1 disorder recurrence prevention trial

Phase 3

• Conditions: Health Condition 1: null- Bipolar 1 disorder recurrence

• Registration Number: CTRI/2012/10/003058
• Lead Sponsor: Forest Research Institute Inc a wholly owned subsidiary of Forest Laboratories LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 550

Inclusion Criteria

1.Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.2.Each participant must be willing and able to provide written informed consent.3.Each participant must have an identified external contact person or an identified responsible person.4.Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TRTM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening.5. Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.Double-Blind Treatment Period6. Each subject must have completed a minimum of 12 weeks and up to 16 weeks of the Open-LabelTreatment Period;7. Each subject must have met one of the following stabilization criteria:a. A Y-MRS and MADRS scores of less than or equal to 12 at either the last 5 consecutive visits of the Open-LabelTreatment Period (ie, visits at Weeks 4, 6, 8, 10, and 12 or visits at Weeks 6, 8, 10, 12, and 14 orWeeks 8, 10, 12, 14, and 16); orb. A Y-MRS and MADRS scores of less than or equal to12 at 5 out of 6 consecutive visits, with only one excursion eventprior to the last visit in the series (the subject met the Y-MRS and MADRS scores at Weeks 6 and 16,and also 3 out of 4 times at Weeks 8, 10, 12, or 14;Note: Subjects must be on asenapine as a monotherapy (ie, previous psychotropic medications already discontinued) for 4 weeks before a stabilization period of 8 weeks can be evaluated. During the 8 week stabilization period an excursion event of Y-MRS and/or MADRS score of less than 16 at a single visit is permitted; excursions of more than or equal to 16 require the subject to be discontinued from the trial.

Exclusion Criteria

1. Uncontrolled, unstable clinically significant medical condition.2. Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.3. Current primary Axis I disorder other than bipolar 1 disorder.4. Meets the current DSM-IV-TRTM criteria forsubstance abuse or dependence (excluding nicotine).5. Imminent risk of self-harm or harm to others

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time (in days) to recurrence of any mood event during the double-blind treatment periodTimepoint: The time (in days) to recurrence of any mood event during the double-blind treatment period