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Trial record 64 of 58361 for:    Placebo

Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder Without Psychotic Features
Interventions Drug: Asenapine 5-20 mg daily
Drug: Placebo 1-4 tablets daily
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Period Title: Overall Study
Started 23 23
Completed 14 23
Not Completed 9 0
Reason Not Completed
Adverse Event             3             0
Withdrawal by Subject             6             0
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily Total
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
44.39  (11.34) 45.87  (12.016) 45.13  (11.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
6
  26.1%
7
  30.4%
13
  28.3%
Male
17
  73.9%
16
  69.6%
33
  71.7%
1.Primary Outcome
Title Change in MADRS Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes those participants who completed week 6 assessment.
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Overall Number of Participants Analyzed 14 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-14.29  (9.73) -11.61  (11.82)
2.Secondary Outcome
Title Study Completion Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Overall Number of Participants Analyzed 23 23
Measure Type: Number
Unit of Measure: percentage of participants
60.87 100
3.Secondary Outcome
Title Clinical Response Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Overall Number of Participants Analyzed 14 23
Measure Type: Number
Unit of Measure: participants
7 12
4.Secondary Outcome
Title Clinical Remission Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Overall Number of Participants Analyzed 14 23
Measure Type: Number
Unit of Measure: participants
5 5
5.Secondary Outcome
Title Rates of Sustained Remission
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all data collection timepoints at week 2, 4, 6.
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

Overall Number of Participants Analyzed 13 23
Measure Type: Number
Unit of Measure: participants
4 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Hide Arm/Group 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

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

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

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

All-Cause Mortality
Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Asenapine 5-20 mg Daily Placebo 1-4 Tablets Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   16/23 (69.57%)   16/23 (69.57%) 
Gastrointestinal disorders     
Oral/ Lingual dysaethesia  5/23 (21.74%)  2/23 (8.70%) 
Nervous system disorders     
orthostasis faintness  2/23 (8.70%)  6/23 (26.09%) 
Psychiatric disorders     
Insomnia  11/23 (47.83%)  11/23 (47.83%) 
Excessive daytime sedation  10/23 (43.48%)  12/23 (52.17%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Beyer, M.D.
Organization: Duke University
Phone: 919-668-0209
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01670019     History of Changes
Other Study ID Numbers: Pro00037462
First Submitted: August 17, 2012
First Posted: August 21, 2012
Results First Submitted: June 29, 2015
Results First Posted: October 1, 2015
Last Update Posted: October 1, 2015