NCT05652153 Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
| NCT ID | NCT05652153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Suicidal Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-25 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-05-25 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to understand why some people act more impulsively when feeling negative emotions, which is called negative urgency. The researchers hope to understand how negative urgency relates to the way networks of brain cells communicate with one another. The researchers will measure negative urgency and brain signals in adolescents aged 13-21 years with depression and suicidal thoughts and behaviors. The main questions it aims to answer are: * Whether a type of brain signaling called cortical inhibition is related to negative urgency * Whether depressed adolescents with suicidal behavior have more problems with cortical inhibition than depressed adolescents with suicidal thoughts only * Whether the relationship between negative urgency and cortical inhibition changes over time Adolescents who participate in the study will complete the following activities at the time they join the study, as well as 6 months and 12 months later: * Interviews with researchers and questionnaires to learn about their thoughts, emotions, and symptoms * A questionnaire about impulsive behaviors and negative urgency * Computerized games that measure brain functions * An MRI scan of the brain * Transcranial magnetic stimulation with electroencephalography (TMS-EEG), a way to measure how brain cells communicate (cortical inhibition) using a magnet placed outside of the head and recording brain signals
Eligibility Criteria
Inclusion Criteria: * Ages 13-21 years (inclusive) * Any sex, gender, race, or ethnicity * For participants 18 years of age or older, ability to provide written informed consent * For participants under 18 years of age, ability to provide written assent, with legal guardian's ability to provide written informed consent * Ability of participant (and parent/guardian, if applicable) to read and to communicate verbally and in writing in English (in order to permit comprehensive assessment of suicide risk by study team, and to facilitate safety planning and mitigation of suicide-related risks as necessary) * Current diagnosis of a unipolar depressive episode (major depressive episode, unspecified depressive disorder, or adjustment disorder with depressed mood), confirmed on the structured diagnostic interview (MINI or MINI-Kid) * For participants in the Dep/SI group: * Any lifetime history of suicidal ideation, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) * No prior history of suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) as assessed by the C-SSRS * For participants in the Dep/SB group: \-- Any lifetime history of suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) as assessed by the C-SSRS * If the study participant will be completing any of the assessments remotely through the use of video teleconferencing, access to a reliable internet connection will be required Exclusion Criteria: * Imminent suicide risk as determined by the PI or other study board-certified child and adolescent psychiatrist (based on review of C-SSRS and SSI scales and clinical assessment of participant) * Current substance use meeting diagnostic criteria for a substance use disorder within the last month on the MINI or MINI-KID diagnostic interview (with the exceptions of caffeine and nicotine) * Lifetime history of psychosis, hypomania, or mania * Historical diagnosis of autism spectrum disorder or intellectual disability * Antiepileptic medication use or chronic benzodiazepine use (as-needed benzodiazepine use will be permitted if it can be held on day of study visit with TMS-EEG testing) * Pregnancy or suspected pregnancy in participants capable of becoming pregnant (assessed with urine pregnancy test) * Medical/neurologic history that would pose increased risks for transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI), or factors that would impede completion of study procedures, including: * Neurological disorders including seizure disorder, history of anoxia, history of head injuries with loss of consciousness for greater than 5 minutes * Suicide attempt by hanging or strangulation (asphyxiation) leading to anoxia * Any personal history of seizure or family history of epilepsy * Any metallic implants, fragments, or devices * Any cardiac pacemaker, medication pump, neural stimulator, or other implanted medical device * Risk for increased intracranial pressure (e.g., history of intracranial mass) * History of intracranial surgical procedure * Any contraindication to TMS determined by the TMS Adult Safety Screen (TASS) * Any contraindication to MRI identified on imaging center screening form * Any non-removable hair, head, or neck body modifications that would impede TMS and proper EEG recording
Contact & Investigator
Kathryn Cullen, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05652153 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 21 Years, studying Suicidal Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05652153 currently recruiting?
Yes, NCT05652153 is actively recruiting participants. Contact the research team at lewi1538@umn.edu for enrollment information.
Where is the NCT05652153 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05652153 clinical trial?
NCT05652153 is sponsored by University of Minnesota. The principal investigator is Kathryn Cullen, MD at University of Minnesota. The trial plans to enroll 80 participants.