Depression - Major Depressive Disorder
Conditions
Keywords
Pharmacogenetics, Pharmacogenomics, Antidepressant Treatment, Precision Medicine, Major Depressive Disorder, Depression, Personalized Medicine
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.
Interventions
DIAGNOSTIC_TESTPharmacogenetic-Guided Treatment
Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.
OTHERUsual 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
Sponsors
Mohammed V University in Rabat
Ibn Sina University Hospital, Rabat, Morocco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Remission | 12 weeks post-randomization | 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. |
| Depression Response | 12 weeks post-randomization | 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. |
| Medication Tolerability | 12 weeks post-randomization | 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. |
| Global Clinical Improvement | 12 weeks post-randomization | 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. |
Countries
Morocco
Contacts
CONTACTMeriem Atarki, PhD
PRINCIPAL_INVESTIGATORMeriem Atarki, PhD
Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco
Outcome results
None listed