Clinical trial NCT00226642: Treatment of Mild and Subthreshold Depressive Disorders
Official title: 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")
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Keywords: depression
primary care
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: HAMD (changes between baseline and individual endpoint)
measure: IDS (changes between baseline and individual endpoint)
Secondary outcomes:
measure: BDI (changes between baseline and individual endpoint)
measure: CGI (changes between baseline and individual endpoint)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians-University, Department of Psychiatry
Study officials:
affiliation: LMU, Department of Psychiatry
name: Ulrich Hegerl, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.