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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2004

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

Primary Measures

• HAM-D
  • Time Frame: 0, 16 weeks, one year
    

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

Lead Sponsor: University of Turku

Overall Clinical Trial Officials and Contacts

Hasse Karlsson, MA, MD, PhD Principal Investigator University of Helsinki  

Information obtained from ClinicalTrials.gov on August 29, 2008

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