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

Connection between treatment outcome of patients, whose depression treatment was started according to standard practice with escitalopram or venlafaxine, and mutations in the genes (CYP2C19, CYP3A4, CYP2D6), which encode enzymes that metabolise antidepressants: 3-month blinded observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN88666791
Enrollment
300
Registered
2014-03-26
Start date
2014-02-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

All participants give a blood sample (10 ml of venous blood), of which genomic DNA is separated in EGCUT's lab according to protocol and genotyping is done based on the TaqMan method. On the basis of

Sponsors

Archimedes Foundation (Estonia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
1. CGI (Clinical Global Impression) evaluates the severity of symptoms, therapeutic effect and treatment efficiency for patients with mental disorders. The Clinical Global Impression ? Severity scale (CGI-S): scale with seven questions allows the doctors to evaluate the severity of symptoms; score 1 normal, not at all ill; 2 borderline mentally ill; 3 mildly ill; 4 moderately ill; 5 markedly ill; 6 severely ill; 7 extremely ill. The Clinical Global Impression - Improvement scale (CGI-I): scale with seven questions allows the doctors to evaluate the changes in the patient's condition (compared to the state at the beginning of the treatment), score: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; 7 very much worse. The Clinical Global Impression - Efficacy index (CGI-EI): includes two sub-scales to allow the doctors to evaluate treatment efficiency; therapeutic effect, score: 1 unchanged to worse; 2 minimal; 3 moderate; 4 marked by side effects; side effects, score: 1 none, 2 do not significantly interfere with patient's functioning, 3 significantly interferes with patient's functioning, 4 outweighs therapeutic effect 2. EEK (Emotional State Questionnaire) subjective self-esteem scale to evaluate the symptoms of depression and anxiety, describe the state of the patients with anxiety- and depressive disorders and observe them dynamically. Patient evaluates the statements on a 5-point scale: 0 never; 1 rarely; 2 sometimes; 3 often; 4 regularly; sub-scale points are summarized in scoring. Sub-scales: anxiety (6 statements/ until score 12); agoraphobia and panic disorder (5/7), depression (8/12), asthenia (5/9), sleep (3/6) 3. MMAS-8 (Morisky Medication Adherence Scale) medication adherence questionnaire consists of 8 questions, the first 7 have yes/no answers (yes=1, no=0). The answer to the last question gives 4,3,2,1 or 0 points, accordingly. The points are added up and the patient's medication adherence is

Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026