Treatment of Mild and Subthreshold Depressive Disorders

NCT00226642 | Unknown Phase 4

• 1 other identifier: KNDS-2.1
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

depression; primary care

Outcome Measures

Primary Outcomes (2)

• HAMD (changes between baseline and individual endpoint)

• IDS (changes between baseline and individual endpoint)

Secondary Outcomes (2)

• BDI (changes between baseline and individual endpoint)

• CGI (changes between baseline and individual endpoint)

Interventions

Sertralin DRUG

Cognitive-behavioral therapy BEHAVIORAL

Placebo DRUG

Non-specific supporting group therapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig-Maximilians-University, Department of Psychiatry

Munich, Germany

Location

Related Publications (4)

• 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.

  PMID: 29355727 DERIVED

• 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.

  PMID: 21959915 DERIVED

• 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.

  PMID: 20975325 DERIVED

• 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.

  PMID: 19341510 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ulrich Hegerl, Prof, MD

  LMU, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Last Updated: September 27, 2005

Record last verified: 2002-02

Locations

DE (1)