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Fluoxetine vs. Brief Psychotherapy for Major Depression

This study has been completed.
Sponsor:
Collaborators:
KELA
Finnish State Grant
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00714779
First received: July 7, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Major Depressive Disorder
 Drug: Fluoxetine
Behavioral: Short-term psychodynamic psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • HAM-D [ Time Frame: 0, 16 weeks, one year ]

Enrollment: 85
Study Start Date: January 2000
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714779

Sponsors and Collaborators
University of Turku
KELA
Finnish State Grant
Investigators
Principal Investigator: Hasse Karlsson, MA, MD, PhD Helsinki University
  More Information

No publications provided

Responsible Party: Professor Hasse Karlsson, University of Turku
ClinicalTrials.gov Identifier: NCT00714779     History of Changes
Other Study ID Numbers: HK123
Study First Received: July 7, 2008
Last Updated: July 7, 2008
Health Authority: Finland: Ethics Committee

Keywords provided by University of Turku:
Major depressive Disorder
fluoxetine
short-term psychodynamic psychotherapy
PET

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013