Treatment outcome improvements by using Rx Report (a pharmacogenomic test) in depressive disorder patients

Not Applicable

• Conditions: Depressive disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN93153882
• Lead Sponsor: Personalized Prescribing Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-25
• Last Update Posted: 11 September 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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