Treatment of Mild and Subthreshold Depressive Disorders

Behandlung Von Leichten Und Unterschwelligen Depressionen. Eine Randomisierte, Kontrollierte Studie Zum Wirksamkeitsnachweis Eines Serotonin-Wiederaufnahme-Hemmers (SSRI), Einer Kognitiven Verhaltenstherapie Und Einer Freien Therapiewahl (Treatment of Mild and Subthreshold Depressive Disorders. A Randomized, Controlled Trial on the Efficacy of a Serotonin-Reuptake-Inhibitor (SSRI), a Cognitive-Behavioral Therapy and of Free Choice Between SSRI and CBT)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226642

Enrollment

369

Registered

2005-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2005-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, primary care

Brief summary

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

Interventions

DRUGSertralin

BEHAVIORALCognitive-behavioral therapy

DRUGPlacebo

BEHAVIORALNon-specific supporting group therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HAMD (changes between baseline and individual endpoint)	—
IDS (changes between baseline and individual endpoint)	—

Secondary

Measure	Time frame
BDI (changes between baseline and individual endpoint)	—
CGI (changes between baseline and individual endpoint)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026