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Treatments for Depression: Drug Versus Psychotherapy

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ClinicalTrials.gov Identifier: NCT00043550
Recruitment Status : Completed
First Posted : August 12, 2002
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Supportive Expressive Therapy Drug: Sertraline Drug: Pill Placebo Drug: Venlafaxine Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression
Study Start Date : November 2001
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Sertraline/Venlafaxine
Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
Drug: Sertraline
Participants will receive sertraline.
Other Name: Zoloft

Drug: Venlafaxine
Participants will receive venlafaxine.
Other Name: Effexor

Active Comparator: 2 Supportive Expressive Therapy
Participants will receive supportive-expressive psychotherapy.
Behavioral: 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.

Placebo Comparator: 3 Pill Placebo
Participants receive placebo.
Drug: Pill Placebo
Participants will receive a pill placebo.




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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Major Depressive Disorder diagnosis

Exclusion criteria:

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043550


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jacques Barber, PhD University of Pennsylvania

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 )
R01MH061410 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Posted: August 12, 2002    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: April 2017

Keywords provided by University of Pennsylvania:
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Venlafaxine Hydrochloride
Serotonin Uptake Inhibitors
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation