RECRUITING

Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

Quick Facts

Study Start:2024-05-25

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05652153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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: * 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	* 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

Inclusion Criteria

Exclusion 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:
* 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

* 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

Contacts and Locations

Study Contact

Charles P Lewis, MD

CONTACT

612-625-4081

lewi1538@umn.edu

Principal Investigator

Kathryn Cullen, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Kathryn Cullen, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-25

Study Completion Date2027-07

Study Record Updates

Study Start Date2024-05-25

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Suicidal Behavior
Suicidal Ideation
Negative Urgency
Cortical Inhibition
Depression