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Treatments for Depression: Drug Versus Psychotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043550
First Posted: August 12, 2002
Last Update Posted: June 2, 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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: August 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Behavioral: Supportive Expressive Therapy
Drug: Sertraline
Drug: Pill Placebo
Drug: Venlafaxine

  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
374 individuals, ages 18 to 70 years, were recruited through advertisements on public transportation, free news publications, area physicians, and outpatient clinics during the period of 2001-2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals not meeting MDD diagnostic criteria11 using the Structured Clinical Interviews for DSM-IV12 or scoring less than 14 on the 17-item Hamilton Rating Scale for Depression (HRSD)13,14 at two evaluations one week apart were excluded (n=88).

Reporting Groups
  Description
1 Sertraline

Participants receive sertraline.

Sertraline : Participants will receive sertraline.

2 Supportive-expressive Psychotherapy

Participants will receive supportive-expressive psychotherapy.

Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.

3 Pill Placebo

Participants receive placebo.

Pill Placebo : Participants will receive a pill placebo.


Participant Flow:   Overall Study
    1 Sertraline   2 Supportive-expressive Psychotherapy   3 Pill Placebo
STARTED   55   51   50 
Week 8 Completed   35   40   35 
COMPLETED   33   39   30 
NOT COMPLETED   22   12   20 
Withdrawal by Subject                22                12                20 



  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
1 Sertraline

Participants receive sertraline.

Sertraline : Participants will receive sertraline.

2 Supportive-expressive Psychotherapy

Participants will receive supportive-expressive psychotherapy.

Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.

3 Pill Placebo

Participants receive placebo.

Pill Placebo : Participants will receive a pill placebo.

Total Total of all reporting groups

Baseline Measures
   1 Sertraline   2 Supportive-expressive Psychotherapy   3 Pill Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   51   50   156 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      55 100.0%      51 100.0%      50 100.0%      156 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.0  (12.5)   36.2  (12.2)   38.3  (12.0)   37.5  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      30  54.5%      31  60.8%      31  62.0%      92  59.0% 
Male      25  45.5%      20  39.2%      19  38.0%      64  41.0% 
Region of Enrollment 
[Units: Participants]
       
United States   55   51   50   156 


  Outcome Measures

1.  Primary:   Hamilton Rating Scale for Depression-17 Item   [ Time Frame: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16 ]


  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
Two limitations are the relatively high level of attrition and small sample size for specific combinations within our moderation analysis.


  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: Jacques P.Barber, PhD, Dean and Professor
Organization: Adelphi University, The Derner Institute of Advanced Psychological Studies
phone: 516.877.4807
e-mail: jbarber@adelphi.edu


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00043550     History of Changes
Other Study ID Numbers: R01MH061410 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Submitted: August 9, 2002
First Posted: August 12, 2002
Results First Submitted: August 26, 2015
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017