Fluoxetine vs. Brief Psychotherapy for Major Depression

University of Turku

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Short-term psychodynamic psychotherapy; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00714779

HK123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

1

Active Comparator group

Description:

Fluoxetine

Treatment:

Drug: Fluoxetine

2

Active Comparator group

Description:

Short-term psychodynamic psychotherapy

Treatment:

Behavioral: Short-term psychodynamic psychotherapy