NCT00596986

Brief Summary

The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

11 months

First QC Date

January 8, 2008

Last Update Submit

July 31, 2009

Conditions

Chronic Depression

Keywords

DepressionDuloxetinePsychotherapyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Neuroimaging Data (fMRI)

    Before and After Therapy

Secondary Outcomes (2)

  • HAMD

    Weekly

  • Salivary Cortisol

    Before and After Therapy

Study Arms (2)

AD

ACTIVE COMPARATOR

Antidepressant Duloxetine

Drug: Duloxetine

PT

ACTIVE COMPARATOR

Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy

Behavioral: Cognitive Behavioural Analysis System of Psychotherapy

Interventions

DuloxetineDRUG

Duloxetine 30mg up to 120mg per day.

AD
Cognitive Behavioural Analysis System of PsychotherapyBEHAVIORAL

Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.

PT

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission)
  • HAMD-24\>20

You may not qualify if:

  • Concurrent Psychotherapy or Psychopharmacotherapy
  • Previous Non-Response to Duloxetine
  • Non-Response to three Antidepressants of two different groups given at adequate doses or Non-Response to two empirically tested forms of Psychotherapy in the current Depressive Episode
  • Serious Psychiatric comorbidity
  • Serious Neurologic comorbidity
  • Contraindications to Duloxetine
  • Contraindications to fMRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin

Berlin, State of Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Isabella Heuser, Prof. Dr. med. Dipl. Psych.

    Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany

    STUDY CHAIR

  • Michael Colla, Dr. med.

    Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

DE(1)