Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

NCT05652153 | Recruiting

• 2 other identifiers: PSYCH-2023-313531K23MH127307
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Long-interval intracortical inhibition (LICI) - baseline

  LICI is a measure of cortical inhibitory physiology that is obtained by recording event-related potentials on electroencephalography (EEG) when applying paired magnetic pulses with transcranial magnetic stimulation (TMS).

  Baseline

• Long-interval intracortical inhibition (LICI) - 6 months

  LICI is a measure of cortical inhibitory physiology that is obtained by recording event-related potentials on electroencephalography (EEG) when applying paired magnetic pulses with transcranial magnetic stimulation (TMS).

  6 months

• Long-interval intracortical inhibition (LICI) - 12 months

  LICI is a measure of cortical inhibitory physiology that is obtained by recording event-related potentials on electroencephalography (EEG) when applying paired magnetic pulses with transcranial magnetic stimulation (TMS).

  12 months

• Negative urgency - baseline

  Negative urgency, the tendency to act impulsively in the context of negative emotion, is measured using a subscale of the self-report Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency (UPPS-P) Impulsive Behavior Scale. Higher scores indicate greater negative urgency.

  Baseline

• Negative urgency - 6 months

  Negative urgency, the tendency to act impulsively in the context of negative emotion, is measured using a subscale of the self-report Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency (UPPS-P) Impulsive Behavior Scale. Higher scores indicate greater negative urgency.

  6 months

• Negative urgency - 12 months

  Negative urgency, the tendency to act impulsively in the context of negative emotion, is measured using a subscale of the self-report Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency (UPPS-P) Impulsive Behavior Scale. Higher scores indicate greater negative urgency.

  12 months

Secondary Outcomes (2)

• Change in long-interval intracortical inhibition (LICI)

  6 months or 12 months

• Change in negative urgency

  6 months or 12 months

Study Arms (1)

Longitudinal Assessments

OTHER

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.

Other: Single-/paired-pulse transcranial magnetic stimulation

Interventions

Single-/paired-pulse transcranial magnetic stimulation OTHER

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.

Longitudinal Assessments

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Kathryn Cullen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles P Lewis, MD

CONTACT

612-625-4081; lewi1538@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two cohorts of adolescents (40 with current depression and prior suicidal ideation, but no prior suicidal behavior, Dep/SI group; 40 with depression and prior suicidal behavior \[an interrupted or aborted attempt, or suicide attempt\], Dep/SB group) will be followed longitudinally for 12 months. Measurement of clinical scales, negative urgency, and neurophysiology (TMS-EEG measurement of cortical inhibition) will be collected at baseline, 6 months, and 12 months. There is no allocation to an intervention.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 15, 2022
• Study Start: May 25, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)