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

Charité University Medicine Berlin

Status: Unknown

Conditions: Chronic Depression

Treatments: Drug: Duloxetine; Behavioral: Cognitive Behavioural Analysis System of Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00596986

EUK-B2.1

EUK-B2

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

AD

Active Comparator group

Description:

Antidepressant Duloxetine

Treatment:

Drug: Duloxetine

PT

Active Comparator group

Description:

Psychotherapy (CBASP) - Cognitive Behavioural Analysis System of Psychotherapy

Treatment:

Behavioral: Cognitive Behavioural Analysis System of Psychotherapy