Fluoxetine vs. Brief Psychotherapy for Major Depression
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine...
Brief Summary
Official Title: “Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study”
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2004
Detailed Clinical Trial Description
This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.
Intervention(s) in this Clinical Trial
- Drug: Fluoxetine
- 20-40 mg / day orally
- Behavioral: Short-term psychodynamic psychotherapy
- 1 session / week for 16 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Fluoxetine
- Active Comparator: 2
- Short-term psychodynamic psychotherapy
Outcome Measures for this Clinical Trial
Primary Measures
- HAM-D
- Time Frame: 0, 16 weeks, one year
- Time Frame: 0, 16 weeks, one year
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- MDD (mild to moderate)
- HDRS 15 or more, age 20-60 years
- No treatment for preceding 4 months
- No DSM-IV axis I or II comorbidity
- No severe somatic illness
- No contraindications for fluoxetine treatment
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Turku Other
Overall Clinical Trial Officials and Contacts
Hasse Karlsson, MA, MD, PhD Principal Investigator Helsinki University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00714779
Study ID Number: HK123
ClinicalTrials.gov Identifier: NCT00714779
Health Authority: Finland: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00714779
