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New treatment option for Suicidal Ideation
Official title iTBS+D-Cycloserine for Youth Suicide
ClinicalTrials.gov ID: NCT06121284
What this study is testing
What is D-Cycloserine?
D-Cycloserine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for suicidal ideation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 treatments are required to save lives.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 24
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- Are currently being treated with GABA agonists such as benzodiazepines, cyclopyrrolones, gabapentin/pregabalin, or anticonvulsant due to the potential to limit TMS how well it works
- Those with a history of intracranial implants or metal, or with any potential metal fragments in the body (particularly in the orbits).
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.