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

NCT00764478 | Completed Phase 3 Results

• 3 other identifiers: P056912010-018409-13MK-8274-003
• Study Type: interventional
• Target: 367
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bipolar 1 Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21

  Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.

  Baseline and Day 21

Secondary Outcomes (22)

• Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21

  Baseline and Day 21

• Percentage of Participants Who Are Y-MRS Responders at Day 21

  Day 21

• Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14

  Baseline and Day 2, Day 4, Day 7 and Day 14

• Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14

  Day 2, Day 4, Day 7, Day 14

• Percentage of Participants Who Are Y-MRS Remitters at Day 21

  Day 21

Study Arms (3)

Asenapine 5 mg BID

EXPERIMENTAL

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

Drug: Asenapine

Asenapine 10 mg BID

EXPERIMENTAL

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

Drug: Asenapine

Placebo BID

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Asenapine DRUG

asenapine tablet, 5 mg sublingually BID for 21 days

Also known as: SCH 900274, Saphris®, Sycrest®, Org 5222

Asenapine 5 mg BID

Placebo DRUG

placebo sublingual tablet, administered BID for 21 days

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Landbloom RL, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. J Affect Disord. 2016 Jan 15;190:103-110. doi: 10.1016/j.jad.2015.06.059. Epub 2015 Sep 25.

  PMID: 26496015 RESULT

MeSH Terms

Interventions

asenapine

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: April 6, 2012
• Primary Completion: April 30, 2014
• Study Completion: May 28, 2014
• Last Updated: June 18, 2024
• Results First Posted: April 24, 2015

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share