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

Pharmacogenetic-Guided Antidepressant Treatment for Major Depressive Disorder: A Randomized Controlled Trial in Morocco

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Diagnostic test: Pharmacogenetic-Guided Treatment; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 570
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meriem Atarki, PhD; Phone Number: +212687595174; Email: meriem_atarki@um5.ac.ma

Study Locations

• Morocco
  • Rabat-Salé-Kénitra
    • Rabat, Rabat-Salé-Kénitra, Morocco, 40000
      • Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital
      • Contact: Meriem Atarki, PhD Candidate; Phone Number: +212687595174; Email: meriem_atarki@um5.ac.ma
      • Contact: Email: meriem_atarki@um5.ac.ma
      • Principal Investigator: Meriem Atarki, PhD Candidate
      • Sub-Investigator: Siham Belbachir, MD
      • Sub-Investigator: Elmostafa El Fahime, PhD
      • Sub-Investigator: Abderrazzak Ouanass, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacogenetic-Guided Treatment	Diagnostic test: Pharmacogenetic-Guided Treatment; Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.; Other Names: PGx-guided prescribing
Active Comparator: Usual Care; Participants receive standard antidepressant treatment according to routine clinical practice without access to pharmacogenetic test results.	Other: Usual Care; Participants in the control group will receive standard antidepressant treatment according to routine clinical practice. Treatment decisions, including antidepressant selection and dose adjustments, will be made by the treating clinician without access to pharmacogenetic test results; Other Names: Standard Clinical Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Severity	Severity of depressive symptoms assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17), a clinician-rated scale ranging from 0 to 52, where higher scores indicate greater depression severity and worse outcomes. The outcome will be analyzed as the change in HAM-D17 total score from baseline to 12 weeks post-randomization. A greater decrease in score reflects greater clinical improvement.	12 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Tolerability	Tolerability of antidepressant treatment assessed using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The FIBSER evaluates three domains (frequency, intensity, and burden of side effects), each scored from 0 to 6, yielding a total score ranging from 0 to 18, where higher total scores indicate greater side effect burden and worse tolerability outcomes.	12 weeks post-randomization
Global Clinical Improvement	Global clinical improvement assessed using the Clinical Global Impression-Improvement (CGI-I) scale, a clinician-rated instrument scored from 1 to 7, where 1 indicates very much improved and 7 indicates very much worse. Lower scores reflect better clinical outcomes.	12 weeks post-randomization
Depression Remission	Depression remission at 12 weeks post-randomization, assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17), a clinician-rated scale ranging from 0 to 52, where higher scores indicate greater depression severity and worse outcomes. Remission is defined as a HAM-D17 total score of 7 or less. The outcome will be analyzed as the proportion of participants meeting remission criteria at week 12.	12 weeks post-randomization
Depression Response	Treatment response at 12 weeks post-randomization, assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17), a clinician-rated scale ranging from 0 to 52, where higher scores indicate greater depression severity and worse outcomes. Response is defined as a reduction of 50 percent or more in HAM-D17 total score from baseline to week 12. The outcome will be analyzed as the proportion of participants meeting response criteria.	12 weeks post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Depression Remission	Sustained remission of depressive symptoms from 12 to 24 weeks post-randomization, assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17), a clinician-rated scale ranging from 0 to 52, where higher scores indicate greater depression severity and worse outcomes. Sustained remission is defined as meeting remission criteria, defined as a HAM-D17 total score of 7 or less, at 12 weeks and remaining in remission at 24 weeks. The outcome will be analyzed as the proportion of participants maintaining remission across both time points.	24 weeks post-randomization

Collaborators and Investigators

• Sponsor: Mohammed V University in Rabat
• Collaborators: Ibn Sina University Hospital, Rabat, Morocco
• Investigators: Principal Investigator: Meriem Atarki, PhD, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Pharmacogenetics; Major Depressive Disorder; Personalized Medicine; Pharmacogenomics; Precision Medicine; Antidepressant Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major
• Other Study ID Numbers: UM5-PGX-DEP-2025; CERB-219-25 (Other Identifier: Biomedical Research Ethics Committee (CERB), Mohammed V University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No