Treatment of Mild and Subthreshold Depressive Disorders

Ludwig-Maximilians - University of Munich369 enrolled

Overview

The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression. Hypotheses: * SSRI is superior to placebo * CBT is superior to a non-specific supporting group therapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

369

Conditions

Depression

Interventions

SertralinDRUG

Cognitive-behavioral therapyBEHAVIORAL

PlaceboDRUG

Non-specific supporting group therapyBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria:(e.g.) * subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22) * informed consent * 18 years Exclusion Criteria:(e.g.) * severe mood disorders * bipolar disorder * recurrent brief depression * suicidality * alcohol or drug dependency * obsessive-compulsive disorder * schizoaffective disorder / schizophrenia * pregnancy

Locations (1)

Ludwig-Maximilians-University, Department of Psychiatry

Munich, Germany

Outcomes

Primary Outcomes

HAMD (changes between baseline and individual endpoint)

IDS (changes between baseline and individual endpoint)

Secondary Outcomes

BDI (changes between baseline and individual endpoint)

CGI (changes between baseline and individual endpoint)

Data from ClinicalTrials.gov

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