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 March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00764478
First received: September 30, 2008
Last updated: March 22, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (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
| United States, Arkansas | |
| Call for Information (Investigational Site 1024) | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Call for Information (Investigational Site 1013) | Recruiting |
| Cerritos, California, United States, 90703 | |
| Call for Information (Investigational Site 1020) | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Call for Information (Investigational Site 1027) | Recruiting |
| Garden Grove, California, United States, 92845 | |
| Call for Information (Investigational Site 1012) | Recruiting |
| Pico Rivera, California, United States, 90660 | |
| Call for Information (Investigational Site 1016) | Recruiting |
| San Diego, California, United States, 92123 | |
| Call for Information (Investigational Site 1021) | Recruiting |
| San Diego, California, United States, 92102 | |
| Call for Information (Investigational Site 1003) | Recruiting |
| San Diego, California, United States, 92103 | |
| United States, District of Columbia | |
| Call for Information (Investigational Site 1010) | Recruiting |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Call for Information (Investigational Site 1023) | Recruiting |
| Bradenton, Florida, United States, 34208 | |
| Call for Information (Investigational Site 1019) | Recruiting |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Call for Information (Investigational Site 1025) | Recruiting |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Call for Information (Investigational Site 1007) | Recruiting |
| Maitland, Florida, United States, 32751 | |
| United States, Louisiana | |
| Call for Information (Investigational Site 1028) | Recruiting |
| Lake Charles, Louisiana, United States, 70629 | |
| United States, Mississippi | |
| Call for Information (Investigational Site 1008) | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Call for Information (Investigational Site 1014) | Recruiting |
| St. Louis, Missouri, United States, 63118 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 1005) | Recruiting |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New York | |
| Call for Information (Investigational Site 1022) | Recruiting |
| Holliswood, New York, United States, 11423 | |
| United States, Ohio | |
| Call for Information (Investigational Site 1026) | Recruiting |
| Dayton, Ohio, United States, 45408 | |
| United States, Pennsylvania | |
| Call for Information (Investigational Site 1015) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Call for Information (Investigational Site 1000) | Recruiting |
| Austin, Texas, United States, 78754 | |
| Call for Information (Investigational Site 1004) | Recruiting |
| Austin, Texas, United States, 78731 | |
| Call for Information (Investigational Site 1002) | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Croatia | |
| Merck Sharp & Dohme d.o.o | Recruiting |
| Zagreb, Croatia | |
| Contact: Andina Hrabar 385 14878400 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00764478 History of Changes |
| Other Study ID Numbers: | P05691, 2010-018409-13 |
| Study First Received: | September 30, 2008 |
| Last Updated: | March 22, 2013 |
| 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 May 23, 2013