Predicting Medication Response in Obsessive Compulsive Disorder
Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: clomipramine (Drug); escitalopram (Drug); duloxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Sunnybrook Health Sciences Centre Official(s) and/or principal investigator(s): Peggy MA Richter, MD FRCPC, Principal Investigator, Affiliation: Sunnybrok Health Sciences Centre; Centre for Addiction and Mental Health; University of Toronto
Summary
In this study, the investigators hope to study a number of variables the investigators
believe may help us predict why some people respond better to some medications than others.
Participants will be randomly assigned to receive one of two typical medications for OCD,
clomipramine or escitalopram. Individuals who would like to participate but who have
previously tried one or both of these medications may instead take a newer drug, duloxetine,
and undergo the identical procedures. The factors the investigators will be studying
include demographics (i. e. age, gender, age of onset of OCD), genetic markers (such as
variants in genes involved in breaking down drugs in the liver (cytochrome P450 system), and
genes involved in several brain chemical systems, such as serotonin), the dimensions of OCD
symptoms (i. e. checking, washing, and hoarding) and cortical inhibition. Cortical
inhibition will be measured transcranial magnetic stimulation and is being studied because
deficits in this process may be important in the development of OCD. The investigators
hypothesize that certain pretreatment clinical characteristics will correlate with poor
treatment response including earlier age of onset, longer duration of illness, increased
YBOCS severity and presence of significant hoarding symptoms. The investigators expect that
increasing degree of deficit in CI pre-treatment will predict poor treatment response, but
that increase in CI from pre- to post-treatment will correlate with a positive treatment
response. Differences in genetic marker status for cytochrome P450 genes will correlate
with tolerability and/or response, as well as differences in genetic marker status in
SLC1A1, GRIN2B, 5HT1B and 5HT2A will correlate with response.
Clinical Details
Official title: Predicting Medication Response in Obsessive Compulsive Disorder
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
Primary outcome: YBOCS Obsessive-Compulsive Severity ScoreClinical Global Improvement - Improvement Scale
Secondary outcome: Change in cortical Inhibition (CI) as measured with Transcranial Magnetic Stimulation.Genotype marker data for SLC1A1, GRIN2B, 5HT1B, 5HT2A and P450 enzymes CYP2D6 and CYP2C19. Tolerability/side effects measure with Udvalg for Liniske Undersogelser Side Effect Rating Scale (UKU). Clinical Global Impression - Severity Scale. Depression symptoms will be rated with the Beck Depression Inventory (BDI). DYBOCS (Dimensional Yale-Brown Obsessive-Compulsive Scale)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Obsessive Compulsive Disorder
- Must be able to swallow tablets
Exclusion Criteria:
- History of stroke
- History of Parkinson's disease
- History of Epilepsy
- Clinical diagnosis of Schizophrenia or schizoaffective disorder
- Clinical diagnosis of Bipolar Affective disorder
- Active suicidality
Locations and Contacts
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
The Centre for Addiction and Mental Health, Toronto, Ontario M5T 1R8, Canada
Additional Information
Starting date: April 2009
Last updated: January 30, 2013
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