Pharmacogenetic-Guided Antidepressant Treatment in Depression

NCT07480486 | Not Yet Recruiting

• 2 other identifiers: UM5-PGX-DEP-2025CERB-219-25
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder

Keywords

Pharmacogenetics; Pharmacogenomics; Antidepressant Treatment; Precision Medicine; Major Depressive Disorder; Depression; Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Depression Remission

  12 weeks post-randomization

• Depression Response

  12 weeks post-randomization

• Medication Tolerability

  12 weeks post-randomization

• Global Clinical Improvement

  12 weeks post-randomization

Other Outcomes (1)

• Sustained Depression Remission

  24 weeks post-randomization

Study Arms (2)

Pharmacogenetic-Guided Treatment

EXPERIMENTAL

Diagnostic Test: Pharmacogenetic-Guided Treatment

Usual Care

ACTIVE COMPARATOR

Participants receive standard antidepressant treatment according to routine clinical practice without access to pharmacogenetic test results.

Other: Usual Care

Interventions

Pharmacogenetic-Guided Treatment DIAGNOSTIC_TEST

Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.

Also known as: PGx-guided prescribing

Pharmacogenetic-Guided Treatment

Usual Care OTHER

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

Also known as: Standard Clinical Care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed V University in Rabat: lead
• Ibn Sina University Hospital, Rabat, Morocco: collaborator

Study Sites (1)

Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital

Rabat, Rabat-Salé-Kénitra, 40000, Morocco

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Meriem Atarki, PhD

  Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meriem Atarki, PhD

CONTACT

+212687595174; meriem_atarki@um5.ac.ma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)