Study on the incidence of genetic polymorphism in patients with major depression who are treated unsatisfactory with antidepressants

• Conditions: Genetic polymorphism of drug metabolizing; F32.2; Severe depressive episode without psychotic symptoms

• Registration Number: DRKS00013497
• Lead Sponsor: STADAPHARM GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-08
• Study Completion: 2020-05-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Outpatients with a diagnosis of major depression
• First drug treatment with one of the following active substances since max. two weeks:
-Citalopram
-Escitalopram
-Amitriptyline
-Venlafaxine
• Age =18 years
• Capacity to consent

Exclusion Criteria

• Comedication with influence on the activity of the enzymes CYP2C19 and CYP2D6
• Intake of St. John's wort preparations
• Consumption of grapefruit and / or products
• Consumption of tryptophan-containing dietary supplements
• Change of medication within the last 3 months
• Hepatic insufficiency (from Child-Pugh-stage A)
• Renal insufficiency stage 3 (glomerular filtration rate <60 ml / min / 1.73 m²)
• Addiction
• Schizophrenia
• Bipolar affective disorder
• Pregnancy or breastfeeding
• Dementia
• Participation in an interventional study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nsatisfactory course of therapy<br>The occurrence of an unsatisfactory course of therapy is recorded. The following events are subsumed as unsatisfactory therapy:<br>• Non-response to the primary prescribed drug within max. 8 weeks after start of therapy and / or<br>• Onset and severity of adverse drug reactions (ADRs) within max. 8 weeks after start of therapy

Secondary Outcome Measures

Name	Time	Method
Polymorphism<br>The presence of a polymorphism of the isoenzymes CYP2C19 and CYP2D6 is assessed by a genetic test using the STADA Diagnostic Antidepressant DNA Test. Based on the result, the patients are divided into the following groups:<br>- No polymorphism<br>- Presence of a polymorphism<br>The group of patients with the present polymorphism is further subdivided into patients with polymorphism of the isoenzyme CYP2C19 or CYP2D6. Both groups are subdivided into subgroups UM, IM and PM.