Asenapine for Bipolar Depression

NCT01807741 | Terminated Phase 2 DMC

• 1 other identifier: 2012-4181
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Bipolar Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Change in Depression Response Rate

  8 weeks

Study Arms (2)

Asenapine Group

EXPERIMENTAL

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

Placebo Group

ACTIVE COMPARATOR

Sublingual tablets similar to the asenapine tablets.

Drug: Placebo

Interventions

Asenapine DRUG

Available in 5 and 10 mg.

Also known as: Saphris

Asenapine Group

Placebo DRUG

Also known as: sugar pill

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet criteria for bipolar depression based on the MINI and confirmation of a previous manic or mixed episode
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• University of Louisville: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45244, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

asenapine; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Caleb M Adler, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (1)