Pharmacogenomic Testing in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Other: Pharmacogenomic testing
- Registration Number
- NCT03228953
- Lead Sponsor
- Columbia University
- Brief Summary
This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.
- Detailed Description
To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- Clinical diagnosis of major depressive disorder (MDD)
- Prescription of index antidepressant medications
- Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
- Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
- Active diagnosis of substance abuse or dependence
- Current suicidal ideation
- Previous suicidal attempts
- A person has already had pharmacogenetic testing done.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacogenomic-guided therapy group Pharmacogenomic testing 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.
- Primary Outcome Measures
Name Time Method Score on the Hamilton Rating Scale for Depression (HAMD-17) 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.
- Secondary Outcome Measures
Name Time Method Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR) 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) 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.
Trial Locations
- Locations (1)
Columbia University Irving Medical Center
🇺🇸New York, New York, United States