Treatment of Mild and Subthreshold Depressive Disorders | NCT00226642

Studies
Treatment of Mild and Subthreshold Depressive Disorders

NCT00226642

Sponsor

Ludwig-Maximilians - University of Munich

Status

Unknown status

Last Update Posted

Sep 27, 2005Estimated

Enrollment

369

Phase

Phase 4

Conditions

Depression

Interventions

Sertralin
Cognitive-behavioral therapy
Placebo
Non-specific supporting group therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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")

Status Module

Record Verification Date

Feb 2002

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 23, 2005

First Submission Date that Met QC Criteria

Sep 23, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2005

Last Update Posted Date

Sep 27, 2005Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

369

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HAMD (changes between baseline and individual endpoint)
IDS (changes between baseline and individual endpoint)

Secondary Outcomes

Measure	Description	Time Frame
BDI (changes between baseline and individual endpoint)
CGI (changes between baseline and individual endpoint)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich Hegerl, Prof, MD	LMU, Department of Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ludwig-Maximilians-University, Department of Psychiatry		Munich			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29355727	Derived	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.
21959915	Derived

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Name	Type	Description	Arm Group Labels	Other Names
Sertralin	Drug
Cognitive-behavioral therapy	Behavioral
Placebo	Drug
Non-specific supporting group therapy	Behavioral