Using brain stimulation and medication to help young people with suicidal thoughts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of intermittent Theta-Burst Transcranial Magnetic Stimulation (iTBS) combined with D-Cycloserine in reducing suicidal ideation among emerging adults aged 18-24. Participants with significant suicidal thoughts and moderate depression will be randomly assigned to receive either the active treatment or a placebo. The study aims to enhance the outcomes of TMS, a non-invasive treatment for depression, by using D-Cycloserine to promote synaptic plasticity in the brain. The trial will assess the safety and efficacy of this combined approach in a double-blind manner.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals aged 18 to 24 years
2. Any sex or gender
3. Are competent to consent to treatment
4. Have previously attempted suicide as defined by the Columbia Suicide Severity Rating Scale
5. 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
6. Moderate depression measured on the 17-item Hamilton Rating Scale for Depression (HAMD-17) ≥15
7. Are able to adhere to the treatment schedule
8. Pass the TMS adult safety screening (TASS) questionnaire
9. Have a normal ECG, CBC, electrolytes, BUN, creatinine, eGFR, AST, ALT, and GGT within the last month.

Exclusion Criteria:

1. Allergy to cycloserine or any excipients due to possible anaphylaxis or other reactions.
2. Current alcohol or substance misuse.
3. Current symptoms or history of psychosis, as this can be aggravated by D-Cycloserine.
4. 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.
5. Have failed a course of ECT in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion.
6. Have previously failed a course of rTMS treatment
7. 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
8. Have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
9. 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.
10. Are currently being treated with GABA agonists such as benzodiazepines, cyclopyrrolones, gabapentin/pregabalin, or anticonvulsant due to the potential to limit TMS efficacy
11. Those with a history of intracranial implants or metal, or with any potential metal fragments in the body (particularly in the orbits).

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Alexander McGirr, MD PhD — University of Calgary
• Study coordinator: Alexander McGirr, MD PhD
• Email: alexander.mcgirr@ucalgary.ca
• Phone: 403 210 6410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.