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Predicting Medication Response in Obsessive Compulsive Disorder

NCT ID: NCT01404871

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Keywords

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OCD pharmacogenetics cortical inhibition genetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Randomization to ECIT or CMI

Randomized trial of clomipramine or escitalopram

Group Type ACTIVE_COMPARATOR

clomipramine

Intervention Type DRUG

oral tablets, starting at 50mg/daily for 12 weeks including \> 8 weeks at 250 mg/daily

escitalopram

Intervention Type DRUG

oral tablet, starting 10mg/daily 12 week treatment including \>8 weeks at max dose 50mg daily

Open label Duloxetine

Open label trial of duloxetine

Group Type ACTIVE_COMPARATOR

duloxetine

Intervention Type DRUG

oral tablets, starting dose 30mg daily 12 week treatment including \>8weeks at 120mg daily

Interventions

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clomipramine

oral tablets, starting at 50mg/daily for 12 weeks including \> 8 weeks at 250 mg/daily

Intervention Type DRUG

escitalopram

oral tablet, starting 10mg/daily 12 week treatment including \>8 weeks at max dose 50mg daily

Intervention Type DRUG

duloxetine

oral tablets, starting dose 30mg daily 12 week treatment including \>8weeks at 120mg daily

Intervention Type DRUG

Other Intervention Names

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Anafranil Cipralex Cymbalta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Obsessive Compulsive Foundation

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peggy Richter

Director, Clinic for OCD & Related Disorders Head, Frederick W. Thompson Anxiety Disorders Centre Dept. of Psychiatry, Sunnybrook Health Sciences Centre Associate Professor of Psychiatry, University of Toronto

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peggy MA Richter, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrok Health Sciences Centre; Centre for Addiction and Mental Health; University of Toronto

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

The Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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OCF-Richter

Identifier Type: -

Identifier Source: org_study_id