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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 Score

Clinical 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

Page last updated: August 23, 2015

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