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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228953
|Contact: Sinan Zhu, PhDemail@example.com|
|Contact: Manuel Cabrera, MDfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Joseph Finkelstein, MD, PhD||Columbia University|