Asenapine in the Treatment of Older Adults With Bipolar Disorder

NCT01460290 | Completed Phase 4 Results DMC

• 1 other identifier: 39358
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be of substantial clinical interest, may inform larger future studies and will assist in refining bipolar treatment recommendations. Hypotheses: Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive symptoms in older adults with BD. Secondary: Asenapine therapy will be associated with improved functional and general health status, improved global psychopathology, and good tolerability in older adults with BD.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)

  The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.

  Baseline and 12 weeks

• Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)

  The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

  Baseline and 12 weeks

Secondary Outcomes (15)

• Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)

  Baseline and 12 weeks

• Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)

  Baseline and 12 weeks

• Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)

  Baseline and 12 weeks

• Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)

  Baseline and 12 weeks

• Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)

  Baseline and 12 weeks

Study Arms (1)

Asenapine

EXPERIMENTAL

12-weeks of open-label asenapine treatment

Drug: Asenapine

Interventions

Asenapine DRUG

Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.

Also known as: Saphris

Asenapine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have type I Bipolar disorder by DSM-IV criteria confirmed on the Mini Neuropsychiatric Interview (MINI)
• Subjects must be age 60 or older
• Subjects must have sub-optimal response to current psychotropic management including at least one of the following:
• Behaviors and symptoms of irritability, agitation, mood lability or diminished ability to interact with others in their place of residence
• Diminished ability to take care of basic personal needs in their place of residence due to symptoms of BD

You may not qualify if:

• History of intolerance or resistance to asenapine
• Clinical diagnosis of dementia or Mini-mental state (MMSE) \< 24
• History of TIA, stroke or MI within the past 12 months
• Medical illness that is the clear, underlying etiology of BD
• Unstable medical illness or condition including prolonged QT interval, which in the opinion of the study investigators, is likely to affect the outcome of the study or the subject's safety
• DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months.
• Rapid cycling BD defined as 4 or more discrete mood episodes within the previous 12 months.
• At high risk for self-harm or suicide

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Martha Sajatovic, Professor of Psychiatry
• Organization: University Hospitals of Cleveland

martha.sajatovic@uhhospitals.org

2168442808

Study Officials

• Martha Sajatovic, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 30, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-12

Locations

US (1)