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Treatment of Mild and Subthreshold Depressive Disorders

NCT ID: NCT00226642

Last Updated: 2005-09-27

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Depression

Keywords

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depression primary care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sertralin

Intervention Type DRUG

Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

Non-specific supporting group therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
* informed consent
* 18 years

Exclusion Criteria

* severe mood disorders
* bipolar disorder
* recurrent brief depression
* suicidality
* alcohol or drug dependency
* obsessive-compulsive disorder
* schizoaffective disorder / schizophrenia
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Hegerl, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

LMU, Department of Psychiatry

Locations

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Ludwig-Maximilians-University, Department of Psychiatry

Munich, , Germany

Site Status

Countries

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Germany

References

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Mergl R, Allgaier AK, Hautzinger M, Coyne JC, Hegerl U, Henkel V. One-year follow-up of a randomized controlled trial of sertraline and cognitive behavior group therapy in depressed primary care patients (MIND study). J Affect Disord. 2018 Apr 1;230:15-21. doi: 10.1016/j.jad.2017.12.084. Epub 2018 Jan 2.

Reference Type DERIVED
PMID: 29355727 (View on PubMed)

Helmreich I, Wagner S, Mergl R, Allgaier AK, Hautzinger M, Henkel V, Hegerl U, Tadic A. Sensitivity to changes during antidepressant treatment: a comparison of unidimensional subscales of the Inventory of Depressive Symptomatology (IDS-C) and the Hamilton Depression Rating Scale (HAMD) in patients with mild major, minor or subsyndromal depression. Eur Arch Psychiatry Clin Neurosci. 2012 Jun;262(4):291-304. doi: 10.1007/s00406-011-0263-x. Epub 2011 Sep 30.

Reference Type DERIVED
PMID: 21959915 (View on PubMed)

Mergl R, Henkel V, Allgaier AK, Kramer D, Hautzinger M, Kohnen R, Coyne J, Hegerl U. Are treatment preferences relevant in response to serotonergic antidepressants and cognitive-behavioral therapy in depressed primary care patients? Results from a randomized controlled trial including a patients' choice arm. Psychother Psychosom. 2011;80(1):39-47. doi: 10.1159/000318772. Epub 2010 Oct 23.

Reference Type DERIVED
PMID: 20975325 (View on PubMed)

Hegerl U, Hautzinger M, Mergl R, Kohnen R, Schutze M, Scheunemann W, Allgaier AK, Coyne J, Henkel V. Effects of pharmacotherapy and psychotherapy in depressed primary-care patients: a randomized, controlled trial including a patients' choice arm. Int J Neuropsychopharmacol. 2010 Feb;13(1):31-44. doi: 10.1017/S1461145709000224. Epub 2009 Apr 3.

Reference Type DERIVED
PMID: 19341510 (View on PubMed)

Other Identifiers

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KNDS-2.1

Identifier Type: -

Identifier Source: org_study_id