Pharmacogenomic Testing in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03228953|
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Other: Pharmacogenomic testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder|
|Estimated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||May 15, 2021|
|Estimated Study Completion Date :||May 15, 2021|
Experimental: Pharmacogenomic-guided therapy group
In this group, results of pharmacogenomic testing will be provided to the treating physician within 2-5 working days. Thus, the patient's treatment provider will be able begin antidepressant adjustments based on pharmacogenomic testing report within a week of the baseline visit.
Other: Pharmacogenomic testing
Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder
No Intervention: Treatment as usual (TAU) group
For patients randomized to this group, medication treatment decisions by the treating clinicians will be made without the availability of the pharmacogenomic report; however, the test results will be provided after the study completion to the patient treating physician.
- Score on the Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: Up to 10 weeks ]The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.
- Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR) [ Time Frame: Up to 10 weeks ]The Quick Inventory of Depressive Symptomatology is a short screening tool based on the larger Inventory of Depressive Symptomatology (IDS). Each item is scored on a scale from 0 to 3 points. Total scores range from 0 (no depression) to 27 (severe depression).
- Score on the 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Up to 10 weeks ]The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days and healthcare utilization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228953
|Contact: Sinan Zhu, PhDfirstname.lastname@example.org|
|Contact: Manuel Cabrera, MDemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Joseph Finkelstein, MD, PhD||Columbia University|