Status:
COMPLETED
Genetic Study of Liver Enzymes in Patients With Side Effects From Antidepressants
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
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 ...
Detailed Description
Study Design This is a naturalistic study of sixty patients, which will include 30 patients who had side significant adverse reactions from treatment with antidepressants metabolized by CYP2D6 and 2C1...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00360256
Start Date
June 1 2006
End Date
December 1 2007
Last Update
April 19 2012
Active Locations (1)
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1
Medical College of Georgia, Dept. of Psychiatry and Health Behavior
Augusta, Georgia, United States, 30912