A Brain Stimulation Treatment for OCD
Summary
We are conducting a treatment study using non-invasive brain stimulation for OCD. The study will test whether pairing stimulation with a medication enhances the treatment. This study involves repetitive transcranial magnetic stimulation, or rTMS, a treatment for OCD. This involves daily sessions of non-invasive brain stimulation over four weeks.
The study is using a medication called cycloserine. As part of the study, you will receive either cycloserine or a placebo with your treatments. A placebo is sometimes referred to as a sugar pill, and contains an inert substance. Some participants will receive sham-rTMS, which is like a placebo for devices like rTMS. This is important to know if the medication is having an independent effect. We will offer real rTMS to those who did not receive a significant benefit during the blinded phase of the study.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 65
Inclusion criteria:
-Males and females
-Aged 18-65
-Primary diagnosis of OCD
-At least moderate severity of symptoms (Yale-Brown Obsessive Compulsive Scale >= 20)
-Did not benefit from one adequate trial of an antidepressant or cognitive behavioral therapy for OCD.
-Stable medications in the 4 weeks prior to beginning trial
-If pursuing psychotherapy, no change to frequency or modality in the last 3 months.
-Are able to adhere to the treatment schedule
Exclusion criteria:
-Have an allergy to cycloserine
-Have an alcohol or substance use disorder within the last 3 months
-Have active suicidal ideation (score of 4 ≥ on item 10 of MADRS)
-Are at a significant risk of harm to themselves or others
-Are currently pregnant , breast feeding or plan to become pregnant
-Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of other primary psychiatric diagnoses as assessed by a study investigator to be primary and causing greater impairment than OCD.
-Are currently taking an anticonvulsant.
-Have failed a course of ECT in the current episode.
-Have a history of non-response to rTMS
-Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, epilepsy, cerebral aneurysm, Parkinson’s disease, Huntington’s chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
-Have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
-Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
-Have a clinically significant laboratory abnormality, in the opinion of study physician
-Are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent).
Participate
Additional information
Contact information
Study Coordinator: Jaeden Cole jaeden.cole1@ucalgary.ca 403-210-6504
Principal investigator:
Alexander McGirr
Clinical trial:
Yes
REB-ID:
REB21-0265