Clomipramine
Drugoral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily
Other names: Anafranil
NCT Number: NCT01404871
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily
Other names: Anafranil
oral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily
Other names: Cipralex
oral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily
Other names: Cymbalta
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.
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.
Time frame: Pre- and post-treatment (typically, 0 weeks and 12 weeks)
Time frame: Collected at week 0, analyzed periodically (approx. 1x/year)
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).
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Time frame: Bi-monthly (every 2 weeks for duration of trial. Approx. 12 weeks)
Time frame: start, middle and end of trial (typically, 0, 6 and 12 weeks)
Sunnybrook Health Sciences Centre
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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