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Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395992
First Posted: July 18, 2011
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

Condition Intervention Phase
Bipolar I Disorder Drug: asenapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Baseline up to 212 days ]

Enrollment: 165
Study Start Date: April 2012
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 5 mg
Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.
Drug: asenapine
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®
Experimental: Asenapine 10 mg
Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.
Drug: asenapine
asenapine 10 mg tablet, SL BID for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
  • Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691

Exclusion criteria:

  • A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
  • A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
  • A participant must not be at imminent risk of self-harm or harm to others
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395992


Locations
United States, Texas
Forest Investigative Site 1000
Austin, Texas, United States, 78754
Sponsors and Collaborators
Forest Laboratories
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01395992     History of Changes
Other Study ID Numbers: P05692
2010-018410-78 ( EudraCT Number )
First Submitted: July 14, 2011
First Posted: July 18, 2011
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Disease
Pathologic Processes
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs