Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01670019
First received: August 17, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.

The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.


Condition Intervention Phase
Major Depressive Disorder Without Psychotic Features
Drug: Asenapine 5-20 mg daily
Drug: Placebo 1-4 tablets daily
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in MADRS total score [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.

    10 items



Secondary Outcome Measures:
  • Study completion rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The percentage of patients still taking their assigned treatment (asenapine or placebo) at the end of 6 weeks

  • Rates of response, remission, and sustained remission [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response will be defined as a > 50% reduction from baseline in MADRS total score. Remission will be defined as a MADRS total score < 7. Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.


Estimated Enrollment: 130
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 5-20 mg daily
Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
Drug: Asenapine 5-20 mg daily
5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
Other Name: SAPHRIS
Placebo Comparator: Placebo 1-4 tablets daily
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Drug: Placebo 1-4 tablets daily
One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Other Name: Placebo

Detailed Description:

The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-130 male or female patients, 18-65 years of age, with:

  1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
  2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
  3. Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication

Exclusion Criteria:

  1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
  2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
  3. Current MDD episode lasting > 12 months
  4. Electroconvulsive therapy within the preceding 6 months
  5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
  6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24)
  7. Risk of suicide as defined by MADRS item 10 score > 4
  8. Prior failure to respond to asenapine
  9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
  10. Hepatic impairment and history of low WBC, by medical history and interview.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670019

Locations
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Carolina Behavioral Care
Durham, North Carolina, United States, 27704
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
North Carolina Psychiatric Research Center
Raleigh, North Carolina, United States, 27603
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: John Beyer, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01670019     History of Changes
Other Study ID Numbers: Pro00037462
Study First Received: August 17, 2012
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Depression
Antidepressant
Antipsychotic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents
Asenapine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014