Treatment of Mild and Subthreshold Depressive Disorders
Primary Purpose
Depression
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sertralin
Cognitive-behavioral therapy
Placebo
Non-specific supporting group therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, primary care
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
Sites / Locations
- Ludwig-Maximilians-University, Department of Psychiatry
Outcomes
Primary Outcome Measures
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)
Secondary Outcome Measures
BDI (changes between baseline and individual endpoint)
CGI (changes between baseline and individual endpoint)
Full Information
NCT ID
NCT00226642
First Posted
September 23, 2005
Last Updated
September 23, 2005
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00226642
Brief Title
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
2. Study Status
Record Verification Date
February 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, primary care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
369 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sertralin
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Non-specific supporting group therapy
Primary Outcome Measure Information:
Title
HAMD (changes between baseline and individual endpoint)
Title
IDS (changes between baseline and individual endpoint)
Secondary Outcome Measure Information:
Title
BDI (changes between baseline and individual endpoint)
Title
CGI (changes between baseline and individual endpoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Hegerl, Prof, MD
Organizational Affiliation
LMU, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ludwig-Maximilians-University, Department of Psychiatry
City
Munich
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29355727
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.
Results Reference
derived
PubMed Identifier
21959915
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.
Results Reference
derived
PubMed Identifier
20975325
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.
Results Reference
derived
PubMed Identifier
19341510
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.
Results Reference
derived
Learn more about this trial
Treatment of Mild and Subthreshold Depressive Disorders
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