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Fluoxetine vs. Brief Psychotherapy for Major Depression

NCT ID: NCT00714779

Last Updated: 2008-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Keywords

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Major depressive Disorder fluoxetine short-term psychodynamic psychotherapy PET

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Fluoxetine

Group Type ACTIVE_COMPARATOR

Fluoxetine

Intervention Type DRUG

20-40 mg / day orally

2

Short-term psychodynamic psychotherapy

Group Type ACTIVE_COMPARATOR

Short-term psychodynamic psychotherapy

Intervention Type BEHAVIORAL

1 session / week for 16 weeks

Interventions

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Fluoxetine

20-40 mg / day orally

Intervention Type DRUG

Short-term psychodynamic psychotherapy

1 session / week for 16 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KELA

UNKNOWN

Sponsor Role collaborator

Finnish State Grant

UNKNOWN

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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University of Turku

Principal Investigators

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Hasse Karlsson, MA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Other Identifiers

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HK123

Identifier Type: -

Identifier Source: org_study_id