Pharmacogenomic Testing in Major Depressive Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 8/5/2017 |
| Start Date: | August 2017 |
| End Date: | May 15, 2021 |
| Contact: | Sinan Zhu, PhD |
| Email: | sz2649@cumc.columbia.edu |
| Phone: | 212-342-0701 |
Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder
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.
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.
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.
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.
Inclusion Criteria:
1. Clinical diagnosis of major depressive disorder (MDD)
2. Prescription of index antidepressant medications
3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Exclusion Criteria:
1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
2. Active diagnosis of substance abuse or dependence
3. Current suicidal ideation
4. Previous suicidal attempts
5. A person has already had pharmacogenetic testing done.
We found this trial at
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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