Suicidal Ideation study: D-Cycloserine
Official title iTBS+D-Cycloserine for Youth Suicide
ClinicalTrials.gov ID: NCT06121284
What this study is testing
What is D-Cycloserine?
This is an investigational antibiotic being studied to see if it helps improve the results of brain stimulation therapy for suicidal thoughts. It is designed to help the brain form new connections, which may make the brain stimulation treatment work better.
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
- The study compares two-week accelerated TMS with either D‑Cycloserine or placebo to see if the drug improves measures of suicide risk and depression. It also looks at whether these changes last up to six months.
- Who it's for
- Young adults aged 18‑24 who have suicidal thoughts or behaviors and also have depression or anxiety.
- What's involved
- Participants receive two TMS treatments per day, one hour apart, for two weeks. They take either D‑Cycloserine or a placebo before the first session. They also complete tests of suicide risk and other assessments during the study.
- Time commitment
- The study lasts two weeks, with daily visits that include two TMS sessions and related tests; follow‑up assessments occur up to six months later.
- 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.
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.
- 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.
- 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.
- 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 is enrolling
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Calgary, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.