Implementation of Individualized Medicine: Education, Prediction and Treatment (IndiMedDep)

Completed

• Conditions: Depressive episode or recurrent depression (F32.1-2 or F33.1-2*)* according to ICD10; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN88666791
• Lead Sponsor: Archimedes Foundation (Estonia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patient has been diagnosed with depressive episode or recurrent depression (F32.1-2 or F33.1-2* according to ICD10)
2. Depressive episode with at least moderate severity must be specified with MADRS point scores (20 points or more)
3. Patient?s age 18?65
4. Patient has not received medicinal treatment with antidepressants at least in the last 3 months
5. According to the attending physician's assessment the patient needs ambulatory treatment for depression with escitalopram or venlafaxine
6. Patient gives an informed consent to participate in the study

Exclusion Criteria

1. Patient has an additional mental disorder (excluding anxiety disorder), that according to the attending physician's evaluation may affect the patient's medication response to antidepressant treatment or affect the patient's participation in the study in some other way
2. Patient has additional severe recurring physical illnesses, that are not in remission and/or their treatment scheme has changed during last 3 months, and which according to the attending physician's evaluation may affect the patient's medication response to antidepressant treatment or affect the patient's participation in the study in some other way
3. Systematic psychotherapy has been started on the patient within the last 3 months
4. To the knowledge of the attending physician, a close relative of the patient participates in the study
5. Sample formation: sequential patients matching the inclusion criteria, who come to the appointments of the doctors participating in the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measured by MADRS (Montgomery?Åsberg Depression Rating Scale) diagnostic interview with ten questions to evaluate the severity of depressive episodes. Highest score indicates a more severe depression. The score of each question varies between 0 and 6 points, the score of the whole questionnaire between 0 and 60 points. The most common cut-off points of the questionnaire score: 0?6 normal /symptom absent; 7?19 mild depression; 20?34 moderate depression, over 34 severe depression.