Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
81 participants
INTERVENTIONAL
2021-11-26
2025-10-31
Brief Summary
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In August 2018, the FDA approved transcranial magnetic stimulation (TMS) for the treatment of OCD based on a large study demonstrating efficacy. Our neurophysiological data and clinical data in depression suggests that we can enhance the effects of TMS by using an adjunctive medication called D-Cyloserine (DCS, 100mg) in conjunction with stimulation. The mechanism by which this is achieved is called synaptic plasticity, or the activity dependent changes that occur with brain stimulation.
Research Question and Objectives: To conduct a randomized sham- and placebo-controlled trial of DCS in adjunct with rTMS in OCD. Participants will be randomized to receive 100mg of DCS or placebo together with TMS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TMS+DCS
The Transcranial Magnetic Stimulation (TMS) involves magnetic stimulation of the brain to the left medial prefrontal cortex (mPFC) daily for four weeks. The stimulation is intermittent Theta-Burst (iTBS).
Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine (DCS) daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of mood disorders.
D-cycloserine
Daily oral D-cycloserine 100mg during TMS treatments (20 days).
TMS+Placebo
The Transcranial Magnetic Stimulation (TMS) involves magnetic stimulation of the brain to the left medial prefrontal cortex (mPFC) daily for four weeks. The stimulation is intermittent Theta-Burst (iTBS).
Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of mood disorders.
Placebo oral capsule
Daily oral placebo during the TMS treatments (20 days).
shamTMS+DCS
Sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered to the brain.
Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine (DCS) daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.
Sham rTMS
Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
D-cycloserine
Daily oral D-cycloserine 100mg during TMS treatments (20 days).
shamTMS+placebo
Sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered to the brain.
Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.
Sham rTMS
Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Placebo oral capsule
Daily oral placebo during the TMS treatments (20 days).
Interventions
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iTBS repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of mood disorders.
Sham rTMS
Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
D-cycloserine
Daily oral D-cycloserine 100mg during TMS treatments (20 days).
Placebo oral capsule
Daily oral placebo during the TMS treatments (20 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. are competent to consent to treatment
3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of DSM-5 criteria Obsessive Compulsive Disorder.
4. have failed to achieve a clinical response to one adequate trial of serotonin reuptake inhibitor or cognitive behavioral therapy with an adequate trial of 2 months medication within the current episode, or been unable to tolerate antidepressant medications.
5. have a score ≥ 20 on the YBOCS.
6. have had no change in dose, or initiation of any psychotropic medication in the 8 weeks prior to randomization
7. are able to adhere to the treatment schedule
8. pass the TMS adult safety screening (TASS) questionnaire
Exclusion Criteria
2. have an alcohol or substance use disorder within the last 3 months
3. have suicidal ideation (score of 4 ≥ on item 10 of MADRS)
4. are at a significant risk of harm to themselves or others
5. Current symptoms of psychosis
6. History of psychosis
7. are currently pregnant , breast feeding or plan to become pregnant
8. 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 Major Depressive Disorder.
9. have failed a course of ECT in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion.
10. history of non-response to rTMS treatment.
11. 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, any history of 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
12. have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
13. 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
14. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
15. are currently (or in the last 4 weeks) taking lorazepam or any other benzodiazepine due to the potential to limit rTMS efficacy
18 Years
65 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Alexander McGirr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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Other Identifiers
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REB21-0265
Identifier Type: -
Identifier Source: org_study_id
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