Understanding Impulsivity in Adolescents with Suicidal Behavior

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the relationship between negative urgency, a tendency to act impulsively during negative emotions, and cortical inhibition in adolescents aged 13-21 who experience depression and suicidal thoughts or behaviors. Researchers will utilize transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) to measure brain signaling and assess how these factors interact over time. Participants will undergo interviews and assessments at the start of the study, as well as at 6 and 12 months, to track changes in their mental health and impulsivity. The findings could provide insights into the neurobiological mechanisms underlying suicidal behavior in adolescents.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Kathryn Cullen, MD — University of Minnesota
• Study coordinator: Charles P Lewis, MD
• Email: lewi1538@umn.edu
• Phone: 612-625-4081

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.