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

Chronic Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:CBASP psychotherapyspecific psychotherapy for chronic depression

Drug:EscitalopramEscitalopram 10-20 mg once daily for the treatment of depression in combination with clinical management

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CBASPCBASP psychotherapy

EscitalopramEscitalopram pharmacotherapy and clinical management

Study Status

Unknown status

Start Date: February 2009

Completed Date: April 2011

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Depressive symptomatology after 8 weeks after randomization as measured by the MADRS

Secondary Outcome: Depressive symptoms and remission 28 weeks after randomization; social, interpersonal and work function 28 weeks after randomization

Study sponsors, principal investigator, and references

Principal Investigator: Claus Normann, MD

Lead Sponsor: University Hospital Freiburg

Collaborator: University Hospital, Bonn

More information:https://clinicaltrials.gov/show/NCT00837564

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