Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691 AM3)

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00764478
First received: September 30, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 objective of the trial is to measure the improvement of the participant's manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.


Condition Intervention Phase
Bipolar 1 Disorder
Drug: Asenapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in Young Mania Rating Scale (YMRS) score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Number of YMRS responders (defined as ≥50% reduction in YMRS total score) [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 366
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 5 mg BID Drug: Asenapine
asenapine tablet, 5 mg sublingually twice daily (BID) for 21 days
Other Name: SCH 900274, Saphris®, Sycrest®, Org 5222
Experimental: Asenapine 10 mg BID Drug: Asenapine
asenapine tablet, 10 mg sublingually BID for 21 days
Other Name: SCH 900274, Saphris®, Sycrest®, Org 5222
Placebo Comparator: Placebo BID Drug: Placebo
placebo sublingual tablet, administered BID for 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764478

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
Croatia
Merck Sharp & Dohme d.o.o Recruiting
Zagreb, Croatia
Contact: Andina Hrabar    385 14878400      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Eran Gefen    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00764478     History of Changes
Other Study ID Numbers: P05691, 2010-018409-13
Study First Received: September 30, 2008
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014