iTBS+D-Cycloserine for Youth Suicide

Launched by UNIVERSITY OF CALGARY · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for young adults aged 18 to 24 who are experiencing thoughts of suicide, depression, or anxiety. The treatment combines a method called intermittent theta-burst stimulation (iTBS), which is a non-invasive brain stimulation technique, with a medication called D-Cycloserine. Researchers believe that this combination may enhance the effectiveness of iTBS and help reduce suicidal thoughts more effectively than iTBS alone. The trial will involve 60 participants who will be randomly assigned to receive either the combination treatment or a placebo (a harmless substance with no active medication) over two weeks.

To participate, individuals must have previously attempted suicide and currently have thoughts of suicide. They should also have moderate depression and meet certain health criteria. Participants will receive the treatment in a controlled setting and will be closely monitored throughout the study. This trial aims to find better treatments for young people who are at risk of suicide, which is a major concern in this age group. If you or someone you know fits the eligibility criteria and is interested in contributing to this important research, reaching out for more information could be a valuable step.

Gender

ALL

Eligibility 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).