Depressive disorders Mental and Behavioural Disorders
Conditions
Interventions
The researchers propose to conduct an ambulatory care-based, open-label, two-arm randomized controlled trial in which patients are randomized to either immediate access to Rx Report with pharmacist gu
Sponsors
Personalized Prescribing Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed depressive disorder (>9 on the Physical Health Questionnaire Version 9 [PHQ-9] screening at baseline in the last 2 years 2. Patients who are on one antidepressant prior to being diagnosed 3. Aged between 18 years and 65 years 4. Have provided written informed consent 5. Have completed sixth grade or higher education in English language to respond to standard questionnaires
Exclusion criteria
Exclusion criteria: 1. Patients on more than two antidepressants at the time of recruitment 2. Acute myocardial infarction in the past 12 months 3. Traumatic brain injury requiring hospitalization in the past 12 months 4. Concussion related emergency or physician visit in the past 5 years 5. Suffering from congestive heart failure 6. Are pregnant and lactating 7. History of epilepsy or seizures 8. Uncontrolled hypertension diagnosed by a physician (consistently elevated systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg) 9. History of concussion in the past 12 months 10. History of stroke 11. Uncontrolled diabetes (HbA1c >8.0%) 12. History of chronic pain 13. History of autoimmune condition 14. History of Bipolar Disorder 15. History of Autism Spectrum Disorder (ASD) 16. History of Attention Deficit Hyperactivity Disorder (ADHD) 17. History of neurodevelopmental disorder (e.g., intellectual disability) 18. History of neurodegenerative disorders (Alzheimer’s disease, Parkinson’s disease, Huntington’s disease etc) 19. History of Schizophrenia Spectrum Disorder 20. History of malignant tumor 21. History of liver failure 22. History of renal insufficiency 23. History of substance misuse treatment 24. Consuming alcohol more than three drinks per day for men (=15/week) or two drinks per day for women (=10/week) or one binge-drinking episode per week. 25. Consuming cannabis or its derived products more than two times per week 26. Consuming illicit substances (not prescribed by physicians) once or more per week 27. History of using anti-depressant medications for conditions other than depression e.g., smoking cessation in the past 5 years 28. History of or planned bariatric surgery within 6 months of pharmacogenomic testing 29. Participants not willing to sign the informed consent 30. Participants unable to respond to standard questionnaires in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured using the Physical Health Questionnaire-9 (PHQ-9) score at baseline and at 3 months and 6 months after the main intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety symptoms measured using the Generalized Anxiety Disorder Scale (GAD-7) score at baseline and at 3 months and 6 months after the main intervention 2. Depression symptoms measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and at 3 months and 6 months after the main intervention | — |
Countries
Canada
Outcome results
None listed