This trial is active, not recruiting.

Condition chronic depression
Treatments duloxetine, cognitive behavioural analysis system of psychotherapy
Sponsor Charite University, Berlin, Germany
Collaborator German Federal Ministry of Education and Research
Start date October 2008
End date September 2009
Trial size 30 participants
Trial identifier NCT00596986, EUK-B2, EUK-B2.1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
(Active Comparator)
Antidepressant Duloxetine
Duloxetine 30mg up to 120mg per day.
(Active Comparator)
Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy
cognitive behavioural analysis system of psychotherapy
Cognitive Behavioural Analysis System of Psychotherapy (CBASP): 20 sessions of psychotherapy, beginning with twice weekly, then weekly sessions.

Primary Outcomes

Neuroimaging Data (fMRI)
time frame: Before and After Therapy

Secondary Outcomes

time frame: Weekly
Salivary Cortisol
time frame: Before and After Therapy

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission) - HAMD-24>20 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

Additional Information

Official title Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias
Principal investigator Michael Colla, Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.