Fluoxetine vs. Brief Psychotherapy for Major Depression

Major Depressive Disorder Clinical Trial

Official title:

Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714779
• Other study ID #: HK123
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: July 7, 2008
• Start date: January 2000
• Est. completion date: December 2004

Study information

• Verified date: July 2008
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Fluoxetine
20-40 mg / day orally

Behavioral:
• Short-term psychodynamic psychotherapy
1 session / week for 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Turku	Finnish State Grant, KELA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D		0, 16 weeks, one year