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Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

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ClinicalTrials.gov Identifier: NCT01670019
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 17, 2012
First Posted Date  ICMJE August 21, 2012
Results First Submitted Date  ICMJE June 29, 2015
Results First Posted Date  ICMJE October 1, 2015
Last Update Posted Date October 1, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
Change in MADRS Total Score [ Time Frame: Baseline, 6 weeks ]
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. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
Change in MADRS Total Score [ Time Frame: 6 weeks ]
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
Change History Complete list of historical versions of study NCT01670019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Study Completion Rate [ Time Frame: 6 weeks ]
    The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks
  • Clinical Response Rate [ Time Frame: Baseline, 6 weeks ]
    Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
  • Clinical Remission Rate [ Time Frame: 6 weeks ]
    Clinical Remission will be defined as the number of participants with a MADRS total score < 7. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
  • Rates of Sustained Remission [ Time Frame: 2, 4, 6 weeks ]
    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. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
Study Completion Rate [ Time Frame: 6 weeks ]
The percentage of patients still taking their assigned treatment (asenapine or placebo) at the end of 6 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
Official Title  ICMJE A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder Without Psychotic Features
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Asenapine 5-20 mg daily
  • 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
    Intervention: Drug: Placebo 1-4 tablets daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2012)
130
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01670019
Other Study ID Numbers  ICMJE Pro00037462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: John Beyer, MD Duke University
PRS Account Duke University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP