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Does Dual Therapy Hasten Antidepressant Response?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519428
First Posted: August 22, 2007
Last Update Posted: October 4, 2017
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.
Collaborators:
University of Ottawa
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: October 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: escitalopram
Drug: bupropion extra long (XL)
Drug: escitalopram + bupropion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment dates: August, 2007 to August 2011 Locations: 4 outpatient research clinics in two countries (US and Canada)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients had to be psychoactive drug-free for at least two weeks (five weeks for fluoxetine) prior to randomization and had to continue to meet study entry criteria at point of randomization

Reporting Groups
  Description
Escitalopram + Bupropion escitalopram plus bupropion
Escitalopram escitalopram monotherapy
Bupropion bupropion monotherapy

Participant Flow:   Overall Study
    Escitalopram + Bupropion   Escitalopram   Bupropion
STARTED   78   84   83 
COMPLETED   57   69   58 
NOT COMPLETED   21   15   25 
Adverse Event                5                2                10 
Lost to Follow-up                7                7                6 
Withdrawal by Subject                8                3                7 
unstated                1                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Escitalopram + Bupropion escitalopram plus bupropion XL
Escitalopram escitalopram monotherapy
Bupropion bupropion XL monotherapy
Total Total of all reporting groups

Baseline Measures
   Escitalopram + Bupropion   Escitalopram   Bupropion   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   84   83   245 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
       
Age   40  (10)   41  (11)   40  (11)   40  (11) 
[1] Patient's report of their age
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      52  66.7%      62  73.8%      49  59.0%      163  66.5% 
Male      26  33.3%      22  26.2%      34  41.0%      82  33.5% 
Region of Enrollment 
[Units: Participants]
       
United States   37   42   41   120 
Canada   41   42   42   125 


  Outcome Measures
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1.  Primary:   Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7   [ Time Frame: 12 weeks ]

2.  Secondary:   Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12   [ Time Frame: 12 weeks ]

3.  Secondary:   Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)   [ Time Frame: 12 weeks ]

4.  Secondary:   Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score   [ Time Frame: 12 weeks ]

5.  Secondary:   Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sample size may have limited demonstration of differences.


  More Information
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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: Jonathan W. Stewart, M.D.
Organization: NYSPInstitute
phone: 212-543-5745
e-mail: jws6@columbia.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00519428     History of Changes
Other Study ID Numbers: 5476
5R01MH076961-04 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2007
First Posted: August 22, 2007
Results First Submitted: October 6, 2016
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017