Cincinnati, Ohio 45244

  • Bipolar Depression

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

2012-4181


NCT ID:

NCT01807741


Secondary ID:


Study Acronym:


Brief Title:

Asenapine for Bipolar Depression


Official Title:

Asenapine for Bipolar Depression


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Cincinnati


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

86


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Caleb M Adler, MD
Principal Investigator
University of Cincinnati
Primary Contact:Emily Rummelhoff
513-558-4295
rummeley@ucmail.uc.edu

Study Dates

Start Date:September 2013
Completion Date:October 2017
Completion Type:Anticipated
Primary Completion Date:July 2017
Primary Completion Type:Anticipated
Verification Date:November 2015
Last Changed Date:May 9, 2016
First Received Date:March 6, 2013

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:Placebo
Arm Name:Placebo Group
Other Name:sugar pill
Intervention Type:Drug
Name:Asenapine
Description:Available in 5 and 10 mg.
Arm Name:Asenapine Group
Other Name:Saphris

Study Arms

Study Arm Type:Active Comparator
Arm Name:Placebo Group
Description:Sublingual tablets similar to the asenapine tablets.
Study Arm Type:Experimental
Arm Name:Asenapine Group
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Cincinnati
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Louisville

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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