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Status unknownNCT00596986GETTYUpdated Aug 3, 2009

Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression

An interventional study of Duloxetine and Cognitive Behavioural Analysis System of Psychotherapy in Chronic Depression, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-08-03.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Depression

Keywords

  • Depression
  • Duloxetine
  • Psychotherapy
  • Magnetic Resonance Imaging
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    AD

    Antidepressant Duloxetine

    Drug: Duloxetine

  • Active comparator
    PT

    Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy

    Behavioral: Cognitive Behavioural Analysis System of Psychotherapy

Interventions

  • DrugDuloxetine

    Duloxetine 30mg up to 120mg per day.

  • BehavioralCognitive Behavioural Analysis System of Psychotherapy

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

06

What researchers measure

Primary outcomes

  1. Neuroimaging Data (fMRI)

    Time frame: Before and After Therapy

Secondary outcomes

  1. HAMD

    Time frame: Weekly

  2. Salivary Cortisol

    Time frame: Before and After Therapy

07

Study locations

1 site
  • Charité Universitätsmedizin
    Berlin, 14050, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00596986
Lead sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
First posted
Jan 17, 2008
Start date
Oct 2008
Primary completion
Sep 2009 (estimated)
Last update
Aug 3, 2009

Study contacts

Isabella Heuser, Prof. Dr. med. Dipl. Psych.
study chair · Dept. of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
Michael Colla, Dr. med.
principal investigator · Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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