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

Chronic Depression Clinical Trial

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Official title:

Impact of Therapeutical Strategies on Emotional Processing in Depression: Neurofunctional and Clinical Issues in the Context of Affective Bias

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00596986
• Other study ID #: EUK-B2.1
• Secondary ID: EUK-B2
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2008
• Last updated: July 31, 2009
• Start date: October 2008

Study information

• Verified date: July 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Duloxetine
Duloxetine 30mg up to 120mg per day.

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

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging Data (fMRI)		Before and After Therapy	No
Secondary	HAMD		Weekly	No
Secondary	Salivary Cortisol		Before and After Therapy	No