Pharmacogenetic-Guided Antidepressant Treatment in Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMohammed V University in Rabat
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pharmacogenetic-Guided Treatment
Diagnostic testPharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.
Usual Care
Other interventionParticipants 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
Treatment groups
570 Participants
are divided into 2 treatment groupsGroup A: Pharmacogenetic-Guided TreatmentExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 weeks post-randomizationSecondary outcomes
1
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.
Time frame
12 weeks post-randomization2
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.
Time frame
12 weeks post-randomization3
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.
Time frame
12 weeks post-randomization4
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.
Time frame
12 weeks post-randomizationOther outcomes
1
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.
Time frame
24 weeks post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mohammed V University in Rabat
Lead sponsor
Ibn Sina University Hospital, Rabat, Morocco
Collaborator
Source ClinicalTrials.gov
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