Depression - Major Depressive DisorderPGX-MDDNCT07480486
Pharmacogenetic-Guided Antidepressant Treatment in Depression
A study testing Pharmacogenetic-Guided Treatment in people with Depression - Major Depressive Disorder, run by Mohammed V University in Rabat at 1 site in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Pharmacogenetic-Guided Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Apr 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morocco1 site
Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital
Rabat, Rabat-Salé-Kénitra, 40000
Meriem Atarki, PhD Candidate, +212687595174, meriem_atarki@um5.ac.ma
meriem_atarki@um5.ac.ma
About this study
Official title: 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.
Read more
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
- Being tested
- Pharmacogenetic-Guided Treatment, Usual Care
- Keywords
- Pharmacogenetics, Pharmacogenomics, Antidepressant Treatment, Precision Medicine, Major Depressive Disorder, Depression, Personalized Medicine
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic-Guided TreatmentDiagnostic test
Also called PGx-guided prescribing
Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.
Usual CareOther
Also called Standard Clinical 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
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic-Guided Treatment | Experimental | Not described Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post-randomization
Secondary outcomes (4)
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.
Measured: 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.
Measured: 12 weeks post-randomization
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.
Measured: 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.
Measured: 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed V University in Rabat
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Sina University Hospital, Rabat, Morocco
- Responsible party
- Principal investigator, Atarki Meriem, Mohammed V University in Rabat
- Investigators
- Meriem Atarki, PhD, Principal investigator, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480486
- Sponsor's protocol ID
- UM5-PGX-DEP-2025
- Other IDs
- CERB-219-25
- Acronym
- PGX-MDD
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic-Guided Antidepressant Treatment for Major Depressive Disorder: A Randomized Controlled Trial in Morocco
- ClinicalTrials.gov ID
- NCT07480486
- Acronym / sponsor ID
- PGX-MDD / UM5-PGX-DEP-2025
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Pharmacogenetics, Pharmacogenomics, Antidepressant Treatment, Precision Medicine, Major Depressive Disorder, Depression, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Mohammed V University in RabatUniversity, hospital or other
- Collaborators
- Ibn Sina University Hospital, Rabat, Morocco
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic-Guided Treatment | Experimental | Diagnostic Test: Pharmacogenetic-Guided Treatment |
| Usual Care | Active comparator | Other: Usual CareParticipants receive standard antidepressant treatment according to routine clinical practice without access to pharmacogenetic test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic-Guided TreatmentAlso: PGx-guided prescribingPharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations. | Diagnostic test | Pharmacogenetic-Guided Treatment |
| Usual CareAlso: Standard Clinical CareParticipants 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 | Usual Care |
Primary outcome
Depression Severity
Time frame: 12 weeks post-randomization
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meriem Atarki, PhD principal investigator
Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic-Guided Treatment in people with Depression - Major Depressive Disorder, run by Mohammed V University in Rabat at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meriem Atarki, PhD (+212687595174, meriem_atarki@um5.ac.ma), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: 12 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.