Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar 1 Disorder

Treatments: Drug: Asenapine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764478

P05691

2010-018409-13 (EudraCT Number)

MK-8274-003 (Other Identifier)

Details and patient eligibility

About

This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.

Enrollment: 367 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Each participant must be at least 18 years of age
• 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
• Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
• Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
• Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion criteria

• A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
• A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
• A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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367 participants in 3 patient groups, including a placebo group

Asenapine 5 mg BID

Experimental group

Description:

Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days

Treatment:

Drug: Asenapine

Drug: Asenapine

Asenapine 10 mg BID

Experimental group

Description:

Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days

Treatment:

Drug: Asenapine

Drug: Asenapine

Placebo BID

Placebo Comparator group

Description:

Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days

Treatment:

Drug: Placebo