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

Conditions: To evaluate different treatment alternatives, including psychological intervention, in depressed patients recruited by screening in participating GP:s waiting-rooms (opportunistic screening). In order to evaluate both milder and more severe forms of depressive disorder and different treatment opportunities, the study will consist of two parts, part A and part B.

Registration Number: EUCTR2007-001450-66-SE

Lead Sponsor: Karolinska Institutet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

10.Pregnant or breast-feeding patients.

11.Patients not fluent in Swedish.