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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-06

Study Completion Date

2014-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)

NCT00145470

Bipolar Disorder

COMPLETED PHASE3

3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

NCT00159796

Bipolar Disorder

COMPLETED PHASE3

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

NCT00145509

Bipolar Disorder

COMPLETED PHASE3

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

NCT01396291

Bipolar 1 Disorder

COMPLETED PHASE3

40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

NCT00159783

Bipolar Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar 1 Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asenapine 5 mg BID

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

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

asenapine tablet, 5 mg sublingually BID for 21 days

Asenapine 10 mg BID

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

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

asenapine tablet, 10 mg sublingually BID for 21 days

Placebo BID

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo sublingual tablet, administered BID for 21 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Asenapine

asenapine tablet, 5 mg sublingually BID for 21 days

Intervention Type DRUG

Asenapine

asenapine tablet, 10 mg sublingually BID for 21 days

Intervention Type DRUG

Placebo

placebo sublingual tablet, administered BID for 21 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SCH 900274, Saphris®, Sycrest®, Org 5222 SCH 900274, Saphris®, Sycrest®, Org 5222

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No