Asenapine for Bipolar Depression

July 20, 2017 updated by: Caleb M. Adler, University of Cincinnati

The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.

We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-blind manner. Patients will receive asenapine (or placebo) beginning on day 0 at 5 mg bid. Dose may be increased to 10 mg bid and adjusted based on clinical response. Patients will be evaluated by a blinded (to treatment status) rater. Patients will be seen and ratings obtained at baseline (day 0) and on days 7, 14, 28, 42, and 56 (or termination from the study). Adverse events will be evaluated as well.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45244
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet criteria for bipolar depression based on the MINI and confirmation of a previous manic or mixed episode
  • 18-55 years of age
  • Female patients must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence)
  • Each patient must understand the nature of the study and must provide written informed consent
  • Patients must have a diagnosis of bipolar disorder, type I and currently display an acute depressive episode as determined by M.I.N.I. (Sheehan et al, 1998)
  • Patients must have a baseline (day 0) MADRS score ≥26
  • Current episode of depression must have persisted for at least one month and no more than six months at study entry
  • Subjects should be fluent in English

Exclusion Criteria:

  • Female patients who are either pregnant or lactating
  • Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions
  • Any history of current or past diabetes that was treated with pharmacological intervention
  • Neurological disorders including epilepsy, stroke, or severe head trauma
  • Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG
  • Depression due to a general medical condition or substance-induced depression (DSM-IV)
  • Mental retardation (IQ <70)
  • Meeting criteria for a mixed episode, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • History of hypersensitivity to or intolerance of asenapine
  • Prior history of asenapine non-response
  • DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months
  • Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline MADRS suicide score of >4)
  • Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry
  • Failure of the current depressive episode to respond to two or more pharmacological interventions
  • Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0
  • Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
  • Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asenapine Group
Asenapine will be given beginning on day 0 at 5 mg bid. Dose will be increased to 10 mg bid if there is less than 50% decrease in MADRS score by week 2. Dose increases may be held if clinically indicated. Doses may be decreased at any time, if clinically indicated, by increments of 5 mg/day to a minimum of 5 mg qHS. Daily treatment with asenapine will be for 8 weeks.
Drug: Asenapine
Available in 5 and 10 mg.
Other Names:
  • Saphris
Active Comparator: Placebo Group
Sublingual tablets similar to the asenapine tablets.
Drug: Placebo
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Score
Time Frame: 8 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS)will be used as a measure of efficacy reflecting change in MADRS total scores from baseline to endpoint over 8 weeks.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Response Rate
Time Frame: 8 weeks
MADRS Response Rate: Defined by a ≥ 50% decrease from baseline to endpoint in MADRS total score over 8 weeks.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Merck Sharp & Dohme LLC
University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-4181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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