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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013497

Enrollment

400

Registered

2017-12-08

Start date

2018-02-22

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Genetic polymorphism of drug metabolizing F32.2

Interventions

Group 1: The course of treatment of patients with major depression treated with citalopram or escitalopram or venlafaxine or amitriptyline is observed. The presence of a genetic polymorphism of the en

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Polymorphism 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: - No polymorphism - Presence of a polymorphism 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.	—

Measure

Time frame

Polymorphism 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: - No polymorphism - Presence of a polymorphism 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.

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Countries

Germany

Contacts

Public ContactSandra Vierich

CSG Clinische Studien Gesellschaft mbH

sandra.vierich@csg-germany.com+49 30 230 809 455

Outcome results

None listed

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