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Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Primary Purpose

Major Depressive Disorder Without Psychotic Features

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Asenapine 5-20 mg daily
Placebo 1-4 tablets daily
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder Without Psychotic Features focused on measuring Depression, Antidepressant, Antipsychotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Georgia Health Sciences University
  • Carolina Behavioral Care
  • Duke University Medical Center
  • Brody School of Medicine at East Carolina University
  • North Carolina Psychiatric Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Asenapine 5-20 mg daily

Placebo 1-4 tablets daily

Arm Description

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

Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability

Outcomes

Primary Outcome Measures

Change in MADRS Total Score
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.

Secondary Outcome Measures

Study Completion Rate
The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks
Clinical Response Rate
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
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
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.

Full Information

First Posted
August 17, 2012
Last Updated
August 31, 2015
Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01670019
Brief Title
Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder Without Psychotic Features
Keywords
Depression, Antidepressant, Antipsychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asenapine 5-20 mg daily
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo 1-4 tablets daily
Arm Type
Placebo Comparator
Arm Description
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Intervention Type
Drug
Intervention Name(s)
Asenapine 5-20 mg daily
Other Intervention Name(s)
SAPHRIS
Intervention Description
5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo 1-4 tablets daily
Other Intervention Name(s)
Placebo
Intervention Description
One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Primary Outcome Measure Information:
Title
Change in MADRS Total Score
Description
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.
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Study Completion Rate
Description
The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks
Time Frame
6 weeks
Title
Clinical Response Rate
Description
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.
Time Frame
Baseline, 6 weeks
Title
Clinical Remission Rate
Description
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.
Time Frame
6 weeks
Title
Rates of Sustained Remission
Description
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.
Time Frame
2, 4, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -130 male or female patients, 18-65 years of age, with: DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI) MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization 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: 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 DSM-IV Axis II diagnoses that significantly impact the current psychiatric status Current MDD episode lasting > 12 months Electroconvulsive therapy within the preceding 6 months Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24) Risk of suicide as defined by MADRS item 10 score > 4 Prior failure to respond to asenapine Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline Hepatic impairment and history of low WBC, by medical history and interview.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Beyer, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Carolina Behavioral Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
North Carolina Psychiatric Research Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States

12. IPD Sharing Statement

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Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

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