Treatments for Depression: Drug Versus Psychotherapy
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Supportive Expressive Therapy
Sertraline
Pill Placebo
Venlafaxine
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder
Eligibility Criteria
Inclusion criteria: Major Depressive Disorder diagnosis Exclusion criteria: Psychotic or bipolar disorder diagnosis Substance dependence in the last 6 months
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1 Sertraline/Venlafaxine
2 Supportive Expressive Therapy
3 Pill Placebo
Arm Description
Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
Participants will receive supportive-expressive psychotherapy.
Participants receive placebo.
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression-17 Item
Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.
Secondary Outcome Measures
Full Information
NCT ID
NCT00043550
First Posted
August 9, 2002
Last Updated
April 28, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00043550
Brief Title
Treatments for Depression: Drug Versus Psychotherapy
Official Title
Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
Detailed Description
MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo.
Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine [Effexor] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.
Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Sertraline/Venlafaxine
Arm Type
Experimental
Arm Description
Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
Arm Title
2 Supportive Expressive Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive supportive-expressive psychotherapy.
Arm Title
3 Pill Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Expressive Therapy
Intervention Description
The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Participants will receive sertraline.
Intervention Type
Drug
Intervention Name(s)
Pill Placebo
Intervention Description
Participants will receive a pill placebo.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
Participants will receive venlafaxine.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression-17 Item
Description
Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.
Time Frame
symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Major Depressive Disorder diagnosis
Exclusion criteria:
Psychotic or bipolar disorder diagnosis
Substance dependence in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Barber, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8916624
Citation
Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996 Oct;64(5):951-8. doi: 10.1037//0022-006x.64.5.951.
Results Reference
result
PubMed Identifier
35913883
Citation
Kuprian N, Aafjes-van Doorn K, Gutterman D, Barber JP. Therapeutic immediacy in psychodynamic psychotherapy for depression: A mixed-method study. Psychotherapy (Chic). 2022 Dec;59(4):554-566. doi: 10.1037/pst0000452. Epub 2022 Aug 1.
Results Reference
derived
PubMed Identifier
30821630
Citation
Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.
Results Reference
derived
PubMed Identifier
29336228
Citation
Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.
Results Reference
derived
PubMed Identifier
28086005
Citation
Zilcha-Mano S, Keefe JR, Chui H, Rubin A, Barrett MS, Barber JP. Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations. J Clin Psychiatry. 2016 Dec;77(12):e1584-e1590. doi: 10.4088/JCP.15m10081.
Results Reference
derived
PubMed Identifier
24176534
Citation
Zilcha-Mano S, Dinger U, McCarthy KS, Barrett MS, Barber JP. Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder. J Affect Disord. 2014 Jan;152-154:538-42. doi: 10.1016/j.jad.2013.10.015. Epub 2013 Oct 16.
Results Reference
derived
PubMed Identifier
22152401
Citation
Barber JP, Barrett MS, Gallop R, Rynn MA, Rickels K. Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Jan;73(1):66-73. doi: 10.4088/JCP.11m06831. Epub 2011 Nov 29.
Results Reference
derived
Learn more about this trial
Treatments for Depression: Drug Versus Psychotherapy
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