Pharmacogenetic-Guided Antidepressant Treatment in Depression (PGX-MDD)

Mohammed V University in Rabat

Status

Not yet enrolling

Conditions

Depression - Major Depressive Disorder

Treatments

Other: Usual Care

Diagnostic Test: Pharmacogenetic-Guided Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07480486

CERB-219-25 (Other Identifier)

UM5-PGX-DEP-2025

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate whether using pharmacogenetic testing to guide antidepressant treatment can improve outcomes in adults with major depressive disorder in Morocco. Depression is a common mental health condition, and finding the most effective antidepressant for a patient can take time. Some individuals do not respond well to the first medication prescribed or may experience side effects.

Pharmacogenetic testing examines genetic variations that can influence how a person processes certain medications. Information about genes involved in drug metabolism, such as CYP2D6 and CYP2C19, may help clinicians choose antidepressants and adjust doses more appropriately for each patient.

The main question this study aims to answer is whether treatment guided by pharmacogenetic test results leads to higher remission rates of depressive symptoms compared with usual clinical care.

In this study, participants diagnosed with major depressive disorder will be randomly assigned to one of two groups. In the pharmacogenetic-guided group, clinicians will receive the patient's genetic test results and may use this information to guide antidepressant selection and dosing. In the usual care group, antidepressant treatment will be prescribed according to standard clinical practice without access to pharmacogenetic information.

Participants will receive antidepressant treatment and will be followed for 12 weeks. During this period, depressive symptoms will be evaluated using standardized clinical questionnaires, including the Patient Health Questionnaire (PHQ-9). Information on treatment response, medication tolerance, and adverse effects will also be collected.

This study aims to provide evidence on the potential role of pharmacogenetic-guided treatment in improving depression management and to support the development of personalized medicine approaches in psychiatric care in Morocco.

Enrollment

570 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of a depressive disorder (major depressive disorder, depressive episode, or persistent depressive disorder) confirmed by a healthcare professional according to DSM-5 or ICD-10 criteria.
Aged 18 years or older at the time of enrollment.
Clinical indication for initiation or modification of antidepressant pharmacotherapy.
Ability to understand study procedures and provide written informed consent.

Exclusion criteria

Inability to provide informed consent.
Current acute psychotic disorder, manic episode, or uncontrolled bipolar disorder.
Current pregnancy or breastfeeding.
Use of medications with clinically significant interactions with antidepressants.
Any severe medical condition that, in the opinion of the investigator, would compromise participant safety or study integrity.