Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 7, 2008
July 7, 2008
January 2000
December 2004   (final data collection date for primary outcome measure)
HAM-D [ Time Frame: 0, 16 weeks, one year ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Fluoxetine
    20-40 mg / day orally
  • Behavioral: Short-term psychodynamic psychotherapy
    1 session / week for 16 weeks
  • Active Comparator: 1
    Fluoxetine
    Intervention: Drug: Fluoxetine
  • Active Comparator: 2
    Short-term psychodynamic psychotherapy
    Intervention: Behavioral: Short-term psychodynamic psychotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
December 2004
December 2004   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00714779
HK123
No
Professor Hasse Karlsson, University of Turku
University of Turku
  • KELA
  • Finnish State Grant
Principal Investigator: Hasse Karlsson, MA, MD, PhD Helsinki University
University of Turku
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP