Using brain stimulation and medication to help young people with suicidal thoughts
A Randomized Placebo-controlled Trial of Adjunctive D-Cycloserine and Accelerated Intermittent Theta Burst Stimulation for Emerging Adults With Suicidal Ideation
This study is testing if a combination of brain stimulation and a medication can help young adults aged 18-24 who have serious thoughts of suicide feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 24 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06121284 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are emerging adults aged 18-24 with a history of suicide attempts and current suicidal ideation.
Not a fit: Patients with active substance misuse or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce suicidal thoughts and improve mental health outcomes for young adults at risk of suicide.
How similar studies have performed: While TMS has shown promise in treating depression, the combination with D-Cycloserine in this specific population is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.