Genetic Study of Liver Enzymes in Patients With Side Effects From Antidepressants
Completed
Conditions studied: Major Depressive Disorder
In brief
The objective of this pilot study is to determine the genetic polymorphism rate of CYP450 2D6 and 2C19 metabolic enzymes in patients with significant adverse effects from antidepressants, compared to a population of patients who had no significant adverse effects from antidepressants metabolized by CYP2D6 and 2C19. The hypothesis for the proposed research is that the rate of 2D6 and 2C19 alleles that are associated with poor metabolizer status in the treatment-intolerant population will far exceed the rate found in patient population who takes antidepressants without adverse effects.
Key facts
- Study ID
- NCT00360256
- Run by
- Augusta University
- People needed
- 46
- Starts
- 2006-06-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2012-04-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients between ages 18 and 65 of any ethnic background
- Diagnosis of major depressive disorder, dysthymic disorder or depressive disorder NOS.
- Experienced side effects on antidepressant metabolized by CYP 2D6 and 2C19 that required discontinuation of treatment
- Experienced side effects from 2 or more antidepressants metabolized by CYP 2D6 and 2C19
You may not qualify if…
- Exclusion criteria:
- Patients with diagnosis of bipolar disorder or any anxiety disorder. We decided to exclude patients with these diagnoses, due to the fact that antidepressants may exacerbate symptoms of bipolar and anxiety disorders and there is a risk that these symptoms can be attributed instead to antidepressant adverse effects.
- Patients taking inhibitors of drugs metabolized by CYP 2D6 and 2C19
- Patients who are non-English speaking: the English version of the UKU side effects rating scale will be used. The rating of side effects depends on the patient interview and the information found in the medical record. To appreciate the extent of the side effects, the rater and the research participant must be speaking the same language. Thus, to include non-English speaking participants, both the research and the clinical staff would need to be fluently bilingual, which is not the case at MCG inpatient and outpatient treatment facilities.
Where it is running
- Medical College of Georgia, Dept. of Psychiatry and Health Behavior — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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