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.
Conditions
Interventions
Trade Name: Cipramil
Pharmaceutical Form: Tablet
Trade Name: Cipralex
Pharmaceutical Form: Tablet
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2.2 Part A 2.2.1 Primary objective • To compare a standard pharmacologic antidepressant treatment (Citalopram) with individual structured psychological intervention in unselected primary care patients diagnosed with mild (MADRS =20) depressive disorder (MDD) undergoing 12 weeks treatment. 2.3 Part B 2.3.1 Primary objective • To evaluate the efficacy of escitalopram in primary care patients considered as non responders to citalopram or psychological treatment in part A, (also including non-responsive primarily citalopram treated patients diagnosed with moderate or severe depression and patients withdrawn on citalopram treatment due to adverse events) ;Secondary Objective: 2.2.2 Secondary objective • To assess if the response to treatment (citalopram or psychological treatment) is related to genetic predisposition regarding the serotonergic transport system and/or thyrosinhydroxyl acid. • To assess effect of treatment with citalopram during 12 weeks in patients with moderate or severe depression (MADRS >20). 2.3.2 Secondary objectives • To assess if the response to secondary treatment with escitalopram in mild or severe depression is related to genetic predisposition regarding the serotonergic transport system and/or thyrosinhydroxylacid. • To assess if the response to primary treatment with escitalpram in severe depression is related to the same genetic predisposition ;Primary end point(s): 2.4 Primary Endpoint In part A and B the effects will be assessed by reduction of scores from baseline on the MADRS-scale to endpoint at 12 weeks | — |
Countries
Sweden
Outcome results
None listed