Treatments for Depression: Drug Versus Psychotherapy - Tabular View

Tracking Information
First Received Date ^ICMJE	August 9, 2002
Last Updated Date	September 19, 2008
Start Date ^ICMJE	November 2001
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 19, 2008)	Hamilton Ratings for Depression [ Time Frame: Measured twice a week for the first 4 weeks, then once a week for the remaining 12 weeks, and again after the first 16 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00043550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatments for Depression: Drug Versus Psychotherapy
Official Title ^ICMJE	Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression
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 evaluated on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are evaluated twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. 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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Depression
Intervention ^ICMJE	Behavioral: Supportive Expressive Therapy Drug: Sertraline Drug: Pill Placebo Drug: Venlafaxine
Study Arms / Comparison Groups	Experimental: Participants receive sertraline. Experimental: Participants will receive venlafaxine. Experimental: Participants will receive supportive-expressive psychotherapy. Placebo Comparator: Participants receive placebo.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	180
Estimated Completion Date	June 2009
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Major Depressive Disorder diagnosis Exclusion criteria: Psychotic or bipolar disorder diagnosis Substance dependence in the last 6 months
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00043550
Responsible Party	Marna Barrett, University of Pennsylvannia
Study ID Numbers ^ICMJE	R01 MH61410, DSIR 83-ATAS
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP