Cognitive Behavioural Analysis System of Psychotherapy (CBASp) Versus Escitalopram in Chronic Depression

University Hospital Freiburg

Status and phase: Unknown; Phase 3

Conditions: Chronic Depression

Treatments: Other: CBASP psychotherapy; Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT00837564

CBASP-1

Details and patient eligibility

About

60 patients with chronic major depressive disorder according to DSM-IV will be included into the study. Patients will be randomized to receive an open treatment either with CBASP, a psychotherapy for chronic depression, or pharmacological treatment with Escitalopram for 28 weeks.

Full description

The psychotherapeutic treatment with CBASP will be conducted in 2 weekly sessions for the first 4 weeks, one per week thereafter until week 9, followed by one session every 2 weeks for 20 more weeks. The starting dose for Escitalopram will be 10 mg/d for one week and will be increased to 20 mg/d after one week. The dosage can be reduced to 10 mg/d after day 7 to improve tolerance. Th MADRS-scale is the primary outcome measure; ratings will be performed by a blinded rater. If there is no improvement (reduction of less than 20% of the MADRS), patients will be crossed over in terms of adding the other treatment at week 8. Study patients will be asked to participate in fMRI, genetic and pharmacological substudies.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic MDD according to DSM-IV (modification: depressive symptomatology for at least one year), or recurrent MDE (third or greater episode with the immediately preceding episode being no more than 2.5 years before the onset of the present episode)
• Age 18-65
• Score of at least 18 on the Montgomery-Asberg-Rating Scale for Depression (MADRS)

Exclusion criteria

• Acute risk for suicide
• History of psychotic symptoms, bipolar disorder or dementia
• Severe substance-related abuse or dependence disorder
• Schizotypal, antisocial or borderline personality disorder
• Serious medical condition
• Severe cognitive impairment
• Absence of a response to previous adequate trial of the study medication/CBASP
• Hypersensitivity to Escitalopram
• Treatment with a MAO-inhibitor within 1 week before the initiation of study treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CBASP

Experimental group

Description:

CBASP psychotherapy

Treatment:

Other: CBASP psychotherapy

Escitalopram

Experimental group

Description:

Escitalopram pharmacotherapy and clinical management

Treatment:

Drug: Escitalopram