Improved management of depression in primary health care –a randomized study of two structured programs with reference to the role of genetic predisposition - Dip Switch study

Karolinska Institutet0 sites300 target enrollmentJune 29, 2007

Overview

No summary available.

Registry

who.int

Start Date

June 29, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patient may be included in the study only if they meet all of the following criteria.
•1\.Male or female age \> 18 years
•2\.Minimum score of 12 points at screening and visit 1 (baseline) on the Montgomery\-Asberg Depression Rating Scale (MADRS\-S).
•3\.A depressive disorder without psychotic features verified by a diagnostic interview based on Prime\-MD
•4\.Female patient of childbearing potential must be using a medical accepted mean of contraception in the judgement of the investigator.
•5\.Each patient must have a level of understanding sufficient to communicate with the investigator and to co\-operate with all test and examinations required by the protocol.
•6\.Each patient must understand the nature of the study and must sign in an informed consent document.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients fulfilling one or more of the following criteria should not be included in the study.
•1\.Contraindications, absolute and relative to citalopram or escitalopram according to the citalopram or escitalopram summary of product characteristics.
•2\.Uncorrected hypothyroidism or hyperthyroidism.
•3\.Substance dependence within the last 6 months except nicotine or caffeine.
•4\.Judged clinically to be at serious suicidal risk.
•5\.Participation in a clinical trial of another investigational drug within 3 months prior to study screening (visit 1\).
•6\.Current or past diagnosis of schizophrenia or other psychotic disorders.
•7\.Patients with grave acting\-out behaviour in the judgement of the investigator
•8\.Patients with ongoing psychotherapy, or psychotherapy within 6 months before study
•9\.Patients on any antidepressive treatment or previous antidepressive treatment within 6 months before study