Status:
RECRUITING
iTBS+D-Cycloserine for Youth Suicide
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of Alberta
Conditions:
Suicidal Ideation
Suicide, Attempted
Eligibility:
All Genders
18-24 years
Phase:
PHASE2
Brief Summary
Background and Rationale: Suicide is the second leading cause of death in Canadian Emerging Adults (EAs; 18-24yrs). Current treatments for suicidal thoughts and behaviors are limited and novel treatme...
Detailed Description
Methods: 54 participants between 18-24 years old with clinically significant past week suicidal ideation, defined as a score ≥4 on item 10 of the Montgomery Asberg Depression Rating Scale (MADRS), at ...
Eligibility Criteria
Inclusion
- Individuals aged 18 to 24 years
- Any sex or gender
- Are competent to consent to treatment
- Have previously attempted suicide as defined by the Columbia Suicide Severity Rating Scale
- Currently have suicidal ideation as defined by a score ≥4 on item 10 of the MADRS in the past week. Individuals with active suicidal ideation, defined as suicidal ideation with the intention to act on a plan that might result in death, are only eligible if currently hospitalized
- Moderate depression measured on the 17-item Hamilton Rating Scale for Depression (HAMD-17) ≥15
- Are able to adhere to the treatment schedule
- Pass the TMS adult safety screening (TASS) questionnaire
- Have a normal ECG, CBC, electrolytes, BUN, creatinine, eGFR, AST, ALT, and GGT within the last month.
Exclusion
- Allergy to cycloserine or any excipients due to possible anaphylaxis or other reactions.
- Current alcohol or substance misuse.
- Current symptoms or history of psychosis, as this can be aggravated by D-Cycloserine.
- Are currently pregnant, breast feeding or plan to become pregnant during the study, as the effects of D-Cycloserine on the fetus are unknown. Health Canada requires that women of reproductive potential utilize either highly effective birth control or double barrier method of contraception. Abstinence is only acceptable when it is the usual and preferred lifestyle of the participant.
- Have failed a course of ECT in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion.
- Have previously failed a course of rTMS treatment
- Have any significant neurological disorder or insult as this increased the risk of adverse events with rTMS 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 15 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 because these can heat or move due to the rapidly alternating magnetic field generated by rTMS.
- Are currently being treated with GABA agonists such as benzodiazepines, cyclopyrrolones, gabapentin/pregabalin, or anticonvulsant due to the potential to limit TMS efficacy
- Those with a history of intracranial implants or metal, or with any potential metal fragments in the body (particularly in the orbits).
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06121284
Start Date
March 11 2024
End Date
September 1 2026
Last Update
November 12 2024
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4