Clinical trial NCT01404871: Predicting Medication Response in Obsessive Compulsive Disorder
Official title: Predicting Medication Response in Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
pharmacogenetics
cortical inhibition
genetics
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Obsessive Compulsive Foundation
name: Centre for Addiction and Mental Health
First posted: 2011-07-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.


Eligibility 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

Primary outcomes:
measure: YBOCS Obsessive-Compulsive Severity Score
timeFrame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
measure: Clinical Global Improvement - Improvement Scale
timeFrame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Secondary outcomes:
measure: Change in cortical Inhibition (CI) as measured with Transcranial Magnetic Stimulation.
timeFrame: Pre- and post-treatment (typically, 0 weeks and 12 weeks)
measure: Genotype marker data for SLC1A1, GRIN2B, 5HT1B, 5HT2A and P450 enzymes CYP2D6 and CYP2C19.
timeFrame: Collected at week 0, analyzed periodically (approx. 1x/year)
measure: Tolerability/side effects measure with Udvalg for Liniske Undersogelser Side Effect Rating Scale (UKU).
timeFrame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
measure: Clinical Global Impression - Severity Scale.
timeFrame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
measure: Depression symptoms will be rated with the Beck Depression Inventory (BDI).
timeFrame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
measure: DYBOCS (Dimensional Yale-Brown Obsessive-Compulsive Scale)
timeFrame: start, middle and end of trial (typically, 0, 6 and 12 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Sunnybrok Health Sciences Centre; Centre for Addiction and Mental Health; University of Toronto
name: Peggy MA Richter, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: