Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

• Status: Terminated
• Trial end date: 2019-08-19
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: AssureRx Health, Inc.
• Treatments: Antidepressive Agents; Antipsychotic Agents; Psychotropic Drugs

Criteria

Inclusion Criteria:

1. Adults 18-65 years of age

2. Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis

3. Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale ≥11

4. Good command of the English language

Exclusion Criteria:

1. Patients with a current diagnosis of schizophrenia

2. Patients with a current diagnosis of schizoaffective disorder

3. Patients with a current diagnosis of bipolar disorder (any type)

4. Currently meeting DSM-IV criteria for significant substance use disorder (exception:

nicotine use disorder)

5. A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator

6. Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment

7. History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months

8. Significant unstable medical condition; life threatening disease; hepatic insufficiency; liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications

9. History of gastric bypass surgery

10. Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator

11. Active psychotic symptoms

12. Currently in an inpatient facility

13. History of prior pharmacogenomic testing

14. Currently pregnant or lactating

15. Inability to provide informed consent

16. Any other factor that in the investigators' judgment may affect patient safety or compliance