search
Back to results

Fluoxetine vs. Brief Psychotherapy for Major Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoxetine
Short-term psychodynamic psychotherapy
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive Disorder, fluoxetine, short-term psychodynamic psychotherapy, PET

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Fluoxetine

    Short-term psychodynamic psychotherapy

    Outcomes

    Primary Outcome Measures

    HAM-D

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2008
    Last Updated
    July 7, 2008
    Sponsor
    University of Turku
    Collaborators
    KELA, Finnish State Grant
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00714779
    Brief Title
    Fluoxetine vs. Brief Psychotherapy for Major Depression
    Official Title
    Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Turku
    Collaborators
    KELA, Finnish State Grant

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Major depressive Disorder, fluoxetine, short-term psychodynamic psychotherapy, PET

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    85 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Fluoxetine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Short-term psychodynamic psychotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoxetine
    Intervention Description
    20-40 mg / day orally
    Intervention Type
    Behavioral
    Intervention Name(s)
    Short-term psychodynamic psychotherapy
    Intervention Description
    1 session / week for 16 weeks
    Primary Outcome Measure Information:
    Title
    HAM-D
    Time Frame
    0, 16 weeks, one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hasse Karlsson, MA, MD, PhD
    Organizational Affiliation
    University of Helsinki
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Fluoxetine vs. Brief Psychotherapy for Major Depression

    We'll reach out to this number within 24 hrs