Status:
COMPLETED
Comparative Effectiveness of Pharmacogenomics for Treatment of Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genetic Alliance
Patient-Centered Outcomes Research Institute
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The overall goal of this study is to assess the effectiveness of a widely available and widely used combinatorial pharmacogenomic (PGx) test for the treatment of major depressive disorder. Pharmacogen...
Detailed Description
Depressive disorders are the fourth leading cause of the burden of disease worldwide and is projected to be the first cause by 2030 1. According to the World Health Organization depression carries the...
Eligibility Criteria
Inclusion
- Ability to give informed consent
- Between the ages of 18-65
- Diagnosed with Major Depressive Disorder (assessed by the Composite International
- Diagnostic Interview Screening Scales (CIDI-SC))
- Currently Depressed (PHQ 9 ≥10)
Exclusion
- Diagnosis of bipolar disorder or schizophrenia
- Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the treating clinician
- Has a general medical condition that is responsible for depressive symptoms or uses a medication responsible for depressive symptoms
- Any medical contraindications for participants to take study medications
- Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months
- Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X Upper Limit of Normal (ULN) for AST and/or ALT); 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
- Patients with a history of gastric bypass surgery. (This exclusion depends on the type of gastric bypass surgery. Those that simply restrict the size of the stomach are acceptable.
- Those that alter the ability of the stomach/digestive lining to absorb nutrients are not. GeneSight is unable to account for absorption issues due to this reason at this time.)
- Patients who self-report to be pregnant or lactating
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03749629
Start Date
May 1 2019
End Date
March 15 2022
Last Update
April 7 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114