NCT00714779

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

4.9 years

First QC Date

July 7, 2008

Last Update Submit

July 7, 2008

Conditions

Major Depressive Disorder

Keywords

Major depressive Disorderfluoxetineshort-term psychodynamic psychotherapyPET

Outcome Measures

Primary Outcomes (1)

  • HAM-D

    0, 16 weeks, one year

Study Arms (2)

1

ACTIVE COMPARATOR

Fluoxetine

Drug: Fluoxetine

2

ACTIVE COMPARATOR

Short-term psychodynamic psychotherapy

Behavioral: Short-term psychodynamic psychotherapy

Interventions

FluoxetineDRUG

20-40 mg / day orally

1
Short-term psychodynamic psychotherapyBEHAVIORAL

1 session / week for 16 weeks

2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Hasse Karlsson, MA, MD, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 14, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

July 14, 2008

Record last verified: 2008-07