Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05652153

Conditions

Suicidal Behavior

Suicidal Ideation

Negative Urgency

Cortical Inhibition

Depression

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Single-/paired-pulse transcranial magnetic stimulation

Study Details

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

Conditions

Suicidal Behavior

Suicidal Ideation

Negative Urgency

Cortical Inhibition

Depression

Study ID

NCT05652153

Start date

May 25, 2024

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Longitudinal Assessments

Participants in both groups (Dep/SI and Dep/SB) will undergo identical assessments at baseline, 6 months, and 12 months. Assessments will include clinical interviews and rating scales, questionnaires (including a self-report scale of negative urgency), and single-/paired-pulse transcranial magnetic stimulation (sp/ppTMS) measurement of cortical inhibition.

Interventions

Single-/paired-pulse transcranial magnetic stimulation

Single-/paired-pulse transcranial magnetic stimulation (sp/ppTMS) is a technique for noninvasive assessment of brain physiology by delivering single or paired magnetic stimuli to the scalp with an electromagnetic coil. This results in transient induction of cortical electrical activity, which can be measured as evoked potentials by electromyography (EMG) and electroencephalography (EEG). Note that sp/ppTMS is used for neurophysiologic measurements; it is distinct from other TMS applications such as repetitive TMS, which can be used as interventions.

Primary outcome measure

  • Long-interval intracortical inhibition (LICI) - baseline [ Time Frame: Baseline ]
  • Long-interval intracortical inhibition (LICI) - 6 months [ Time Frame: 6 months ]
  • Long-interval intracortical inhibition (LICI) - 12 months [ Time Frame: 12 months ]
  • Negative urgency - baseline [ Time Frame: Baseline ]
  • Negative urgency - 6 months [ Time Frame: 6 months ]
  • Negative urgency - 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Charles P Lewis, MD

612-625-4081lewi1538@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Suicidal Behavior
  • Suicidal Ideation
  • Negative Urgency
  • Cortical Inhibition
  • Depression
  • Adolescent
  • Transcranial Magnetic Stimulation
  • Electroencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-06-23.