Fluoxetine vs. Brief Psychotherapy for Major Depression

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Fluoxetine; Behavioral: Short-term psychodynamic psychotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Fluoxetine	Drug: Fluoxetine; 20-40 mg / day orally
Active Comparator: 2; Short-term psychodynamic psychotherapy	Behavioral: Short-term psychodynamic psychotherapy; 1 session / week for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HAM-D	0, 16 weeks, one year

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: KELA; Finnish State Grant
• Investigators: Principal Investigator: Hasse Karlsson, MA, MD, PhD, University of Helsinki

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2008
• Last Update Submitted That Met QC Criteria: July 7, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: PET; Major depressive Disorder; fluoxetine; short-term psychodynamic psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: HK123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No