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Behavioural Intervention

D-Cycloserine + TMS for Obsessive-Compulsive Disorder

Phase 2
Waitlist Available
Led By Alexander McGirr, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Males and females aged 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
Awards & highlights

Study Summary

This trial will help determine if D-Cyloserine, when used alongside transcranial magnetic stimulation, is an effective treatment for Obsessive Compulsive Disorder.

Who is the study for?
Adults aged 18-65 with a confirmed diagnosis of Obsessive Compulsive Disorder (OCD) who haven't responded to certain treatments and have a score ≥ 20 on the YBOCS. Participants must not have changed psychotropic medications in the last 8 weeks, be able to consent, adhere to treatment schedules, and pass TMS safety screenings. Exclusions include allergy to cycloserine, recent substance abuse, suicidal ideation, psychosis history, pregnancy or breastfeeding women, unstable medical conditions or metal implants near the head.Check my eligibility
What is being tested?
The trial is testing if D-cycloserine (DCS), when taken with repetitive Transcranial Magnetic Stimulation (rTMS), can improve OCD symptoms compared to placebo. It's randomized: participants will either get real rTMS with DCS or sham rTMS with a placebo capsule without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects may include discomfort at stimulation site from rTMS; headache; dizziness; scalp tingling during rTMS sessions; seizures are rare but possible. For D-cycloserine: allergic reactions like rash or fever; mood changes such as anxiety or confusion might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I tried an antidepressant or therapy for 2 months without improvement or couldn't tolerate the medication.
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I am between 18 and 65 years old.
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I haven't changed or started any mental health medication in the last 8 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Yale-Brown Obsessive Compulsive Scale (YBOCs)
Secondary outcome measures
Change in Cognitive Function - THINC-it- Choice Reaction Time
Change in Cognitive Function - THINC-it- Digit Symbol Substitution
Change in Cognitive Function - THINC-it- PDQ-5
+20 more
Other outcome measures
Incidence of Treatment-Emergent Adverse Events
Side Effects

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: TMS+DCSActive Control2 Interventions
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.
Group II: TMS+PlaceboActive Control2 Interventions
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.
Group III: shamTMS+DCSPlacebo Group2 Interventions
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.
Group IV: shamTMS+placeboPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,653 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
140 Patients Enrolled for Obsessive-Compulsive Disorder
Alexander McGirr, MD, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

iTBS repetitive Transcranial Magnetic Stimulation (rTMS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05177601 — Phase 2
Obsessive-Compulsive Disorder Research Study Groups: TMS+DCS, TMS+Placebo, shamTMS+DCS, shamTMS+placebo
Obsessive-Compulsive Disorder Clinical Trial 2023: iTBS repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT05177601 — Phase 2
iTBS repetitive Transcranial Magnetic Stimulation (rTMS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177601 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the patient capacity for this research trial?

"Affirmative, according to the information posted on clinicaltrials.gov this study is actively accepting participants. The trial was initially launched in November 2021 and has been updated most recently in March 2022; it's currently recruiting 81 individuals from a single medical centre."

Answered by AI

Are individuals over the age of 65 eligible to partake in this trial?

"This medical trial is open to patients aged 18-65. For those outside of this range, there are 24 studies for persons below the age of majority and 74 for seniors over 65 years old."

Answered by AI

To what end are Transcranial Magnetic Stimulation and Direct Current Stimulation commonly employed?

"Transcranial magnetic stimulation and Direct Current Stimulation are often employed to treat those who have failed conventional therapy. Additionally, TMS+DCS has been found effective for treating inadequate response to traditional therapies, tuberculosis, extrapulmonary TB (tb), as well as pulmonary tb cases."

Answered by AI

What potential risks are associated with Transcranial Magnetic Stimulation and Direct Current Stimulation treatments?

"Due to the Phase 2 status of this trial, our team assessed that TMS+DCS has a safety score of 2. This is because there are case studies demonstrating its safety but none yet proving efficacy."

Answered by AI

Has a combination of transcranial magnetic stimulation and direct current stimulation ever been studied before?

"Presently, there are 9 extant studies investigating the effectiveness of TMS+DCS. Of these trials, 2 have reached Phase 3. All in all 23 medical centres across America are running such clinical experiments. Notably, a substantial number of these facilities can be found near Baltimore, MD."

Answered by AI

Who qualifies to participate in this clinical trial?

"This clinical trial is open to 81 individuals aged between 18 and 65 with a DSM-5 diagnosis of obsessive-compulsive disorder, who have failed to respond adequately to serotonin reuptake inhibitors or cognitive behavioral therapy. Additionally, YBOCS scores must be 20 or higher and participants must pass the TMS adult safety screening questionnaire. Finally, no changes in dose nor initiation of any psychotropic medication should occur 8 weeks prior to randomization."

Answered by AI

Are there any places available in this experiment for prospective participants?

"Affirmative. The clinical trial is open for enrolment, as per the latest details on clinicaltrials.gov - it was first published on November 26th 2021 and last edited March 22nd 2022. They are hoping to find 81 individuals from 1 medical centre to take part in this experiment."

Answered by AI

Who else is applying?

What site did they apply to?
University of Calgary
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
iTBS-DCS in Obsessive Compulsive Disorder
2021. "iTBS-DCS in Obsessive Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05177601.
All > Obsessive Compulsive Disorder > Ocd
~12 spots leftby Oct 2024
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