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Not yet recruiting NCT07480486

Pharmacogenetic-Guided Antidepressant Treatment in Depression

No phase Interventional Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacogenetic-Guided Treatment, Usual Care.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Morocco
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 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

Primary outcome measures

  • Depression Severity [Time frame: 12 weeks post-randomization]
Secondary outcome measures (4)
  • Depression Remission [Time frame: 12 weeks post-randomization]
  • Depression Response [Time frame: 12 weeks post-randomization]
  • Medication Tolerability [Time frame: 12 weeks post-randomization]
  • Global Clinical Improvement [Time frame: 12 weeks post-randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Morocco · 1 center
  • Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital — Rabat

Identifiers

NCT: NCT07480486 · UM5-PGX-DEP-2025 · CERB-219-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗