Obsessive Compulsive DisorderNCT01404871
Predicting Medication Response in Obsessive Compulsive Disorder
A study testing clomipramine, escitalopram and duloxetine in people with Obsessive Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- clomipramine, escitalopram and duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Obsessive Compulsive Disorder
- Must be able to swallow tablets
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
The Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- clomipramine, escitalopram, duloxetine
- Keywords
- OCD, pharmacogenetics, cortical inhibition, genetics
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clomipramineDrug
Also called Anafranil
oral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily
escitalopramDrug
Also called Cipralex
oral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily
duloxetineDrug
Also called Cymbalta
oral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily
| Study group | Role | What they receive |
|---|---|---|
| Randomization to ECIT or CMI | Active comparator | Randomized trial of clomipramine or escitalopram Receives: Drug: clomipramine; Drug: escitalopram |
| Open label Duloxetine | Active comparator | Open label trial of duloxetine Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS Obsessive-Compulsive Severity Score
The YBOCS yields an OCD severity score by scoring participants on time, interference, distress, resistance and control of their obsessive and compulsive symptoms on a scale of 0-4. When these scores are summed, they give a total severity score from 0-40. The primary outcome will measure the degree of change in this measurement from pre- to post-treatment.
Measured: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Clinical Global Improvement - Improvement Scale
This is a clinician/Research assistant rated score of clinical improvement. Both treating physician and research assistant (who interviews the participant every two weeks) will independently provide ratings from 1-7, 1 being very much improved and 7 being very much worse.
Measured: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Secondary outcomes (6)
Change in cortical Inhibition (CI) as measured with Transcranial Magnetic Stimulation.
Measured: Pre- and post-treatment (typically, 0 weeks and 12 weeks)
Genotype marker data for SLC1A1, GRIN2B, 5HT1B, 5HT2A and P450 enzymes CYP2D6 and CYP2C19.
We will initially focus on GLU and GABA gene candidates for which there is good evidence of involvement in cortical inhibition. We will also prioritize other markers previously implicated in response and/or etiology of the illness including 5HT1B, 5HT2A, 5HTT, DRD3, DRD4, MOG, BDNF, MAOA, COMT. We will test 200 SNPs across these 12 genes, and also explore any highly promising genes emerging from the literature as time and resources permit. We will test both single markers and haplotypes. Genotyping of CYP2D6 and CYP2C19 will be typed by the Roche Diagnostics Amplichip (www.amplichip.us).
Measured: Collected at week 0, analyzed periodically (approx. 1x/year)
Tolerability/side effects measure with Udvalg for Liniske Undersogelser Side Effect Rating Scale (UKU).
Measured: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Clinical Global Impression - Severity Scale.
Measured: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Depression symptoms will be rated with the Beck Depression Inventory (BDI).
Measured: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
DYBOCS (Dimensional Yale-Brown Obsessive-Compulsive Scale)
Measured: start, middle and end of trial (typically, 0, 6 and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Obsessive Compulsive Foundation, Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Dr. Peggy Richter, Sunnybrook Health Sciences Centre
- Investigators
- Peggy MA Richter, MD FRCPC, Principal investigator, Sunnybrok Health Sciences Centre; Centre for Addiction and Mental Health; University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404871
- Sponsor's protocol ID
- OCF-Richter
- Status last verified
- Jan 2013
- First submitted
- 6 Feb 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Medication Response in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01404871
- Acronym / sponsor ID
- OCF-Richter
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, pharmacogenetics, cortical inhibition, genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Obsessive Compulsive Foundation, Centre for Addiction and Mental Health
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomization to ECIT or CMI | Active comparator | Drug: clomipramine, Drug: escitalopramRandomized trial of clomipramine or escitalopram |
| Open label Duloxetine | Active comparator | Drug: duloxetineOpen label trial of duloxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Obsessive Compulsive Disorder
- Must be able to swallow tablets
Key exclusion criteria (6 listed)
- History of stroke
- History of Parkinson's disease
- History of Epilepsy
- Clinical diagnosis of Schizophrenia or schizoaffective disorder
- Clinical diagnosis of Bipolar Affective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clomipramineAlso: Anafraniloral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily | Drug | Randomization to ECIT or CMI |
| escitalopramAlso: Cipralexoral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily | Drug | Randomization to ECIT or CMI |
| duloxetineAlso: Cymbaltaoral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily | Drug | Open label Duloxetine |
Primary outcome
YBOCS Obsessive-Compulsive Severity Score
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
The YBOCS yields an OCD severity score by scoring participants on time, interference, distress, resistance and control of their obsessive and compulsive symptoms on a scale of 0-4. When these scores are summed, they give a total severity score from 0-40. The primary outcome will measure the degree of change in this measurement from pre- to post-treatment.
Clinical Global Improvement - Improvement Scale
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
This is a clinician/Research assistant rated score of clinical improvement. Both treating physician and research assistant (who interviews the participant every two weeks) will independently provide ratings from 1-7, 1 being very much improved and 7 being very much worse.
6 secondary outcomes
Change in cortical Inhibition (CI) as measured with Transcranial Magnetic Stimulation.
Time frame: Pre- and post-treatment (typically, 0 weeks and 12 weeks)
Genotype marker data for SLC1A1, GRIN2B, 5HT1B, 5HT2A and P450 enzymes CYP2D6 and CYP2C19.
Time frame: Collected at week 0, analyzed periodically (approx. 1x/year)
Tolerability/side effects measure with Udvalg for Liniske Undersogelser Side Effect Rating Scale (UKU).
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Clinical Global Impression - Severity Scale.
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Depression symptoms will be rated with the Beck Depression Inventory (BDI).
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
DYBOCS (Dimensional Yale-Brown Obsessive-Compulsive Scale)
Time frame: start, middle and end of trial (typically, 0, 6 and 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy MA Richter, MD FRCPC principal investigator
Sunnybrok Health Sciences Centre; Centre for Addiction and Mental Health; University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clomipramine, escitalopram and duloxetine in people with Obsessive Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YBOCS Obsessive-Compulsive Severity Score (time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.