Differential responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP) versus Escitalopram in chronic major depression with and without early trauma.
Conditions
Interventions
Trade Name: Cipralex 10 mg
Product Name: Cipralex
Pharmaceutical Form: Film-coated tablet
Sponsors
Dept. of Psychiaty, University of Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
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 preceeding 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether in patients with chronic Major Depressive Disorder (MDD) and early life trauma, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is superior to escitalopram plus Clinical Management in reducing depressive symptoms and leads to higher remission rates.;Secondary Objective: It is important to find effective treatment strategies for chronic depression since it is a common (roughly a third of all depressive disorders take a chronic course) and a particularly disabling disorder which is associated with greater comorbidity, more significant impairments in functioning, increased health care utilisation, and more frequent suicide attempts and hospitalisations than acute major depressive episodes (Arnow et al., J Clin Psychol, 2003). So far, chronic depressions are considered as treatment resistant by most clinicians. Chronically depressed patients account for a major part of the patients requiring hospitalisation;Primary end point(s): MADRS score at week 8. | — |
Countries
Germany
Outcome results
None listed