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Treatment of Mild and Subthreshold Depressive Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2002 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00226642
First received: September 23, 2005
Last updated: NA
Last verified: February 2002
History: No changes posted
  Purpose

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

Condition Intervention Phase
Depression
 Drug: Sertralin
Behavioral: Cognitive-behavioral therapy
Drug: Placebo
Behavioral: Non-specific supporting group therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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")

Resource links provided by NLM:

MedlinePlus related topics: Depression
Drug Information available for: Serotonin
U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

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)

Estimated Enrollment: 369
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226642

Locations
Germany
Ludwig-Maximilians-University, Department of Psychiatry
Munich, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Ulrich Hegerl, Prof, MD LMU, Department of Psychiatry
  More Information

No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00226642     History of Changes
Other Study ID Numbers: KNDS-2.1
Study First Received: September 23, 2005
Last Updated: September 23, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
depression
primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013