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Asenapine for Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Asenapine
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar Disorder, Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asenapine Group

Placebo Group

Arm Description

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.

Sublingual tablets similar to the asenapine tablets.

Outcomes

Primary Outcome Measures

Change in Depression Score
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2013
Last Updated
July 20, 2017
Sponsor
University of Cincinnati
Collaborators
University of Louisville, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01807741
Brief Title
Asenapine for Bipolar Depression
Official Title
Asenapine for Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
funding ended due to recruitment delays
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
University of Louisville, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar Disorder, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asenapine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Active Comparator
Arm Description
Sublingual tablets similar to the asenapine tablets.
Intervention Type
Drug
Intervention Name(s)
Asenapine
Other Intervention Name(s)
Saphris
Intervention Description
Available in 5 and 10 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Primary Outcome Measure Information:
Title
Change in Depression Score
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Depression Response Rate
Description
MADRS Response Rate: Defined by a ≥ 50% decrease from baseline to endpoint in MADRS total score over 8 weeks.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caleb M Adler, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45244
Country
United States

12. IPD Sharing Statement

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Asenapine for Bipolar Depression

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