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NCT05652153
Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
Conditions: Suicidal Behavior, Suicidal Ideation, Negative Urgency, Cortical Inhibition, Depression
Sex: All
Ages: 13 Years – 18 Years
Phase: NA
Enrollment: 80
Sponsor: University of Minnesota
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 13-18 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 urgencyWhether depressed adolescents with suicidal behavior have more problems with cortical inhibition than depressed adolescents with suicidal thoughts onlyWhether the relationship between negative urgency and cortical inhibition changes over timeAdolescents 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 symptomsA questionnaire about impulsive behaviors and negative urgencyComputerized games that measure brain functionsAn MRI scan of the brainTranscranial 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 13-18 years (inclusive)Any sex, gender, race, or ethnicityFor participants 18 years of age, ability to provide written informed consentFor participants under 18 years of age, ability to provide written assent, with legal guardian's ability to provide written informed consentAbility of participant and parent/guardian 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)For participants in the Dep/SI group, 1) current diagnosis of a unipolar depressive episode (major depressive episode, unspecified depressive disorder, or adjustment disorder with depressed mood); 2) suicidal ideation occurring within the 3 months preceding study enrollment, as measured by the Columbia Suicide Severity Rating Scale (C-SSRS); and 3) no prior history of suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) as measured by the C-SSRSFor participants in the Dep/SB group, 1) current diagnosis of a unipolar depressive disorder (major depressive episode, unspecified depressive disorder, or adjustment disorder with depressed mood); and 2) suicidal behavior (interrupted attempt, aborted attempt, or suicide attempt) within the 3 months preceding study enrollment as measured by the C-SSRSExclusion 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 Beck Scale for Suicide Ideation (SSI) scales and clinical assessment of participant)Current substance use meeting diagnostic criteria for a substance use disorder (with the exceptions of caffeine and nicotine) within the last month on the Mini-International Neuropsychiatric Interview (MINI; if age 18 years) or Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID, if age < 18 years) diagnostic interviewLifetime history of psychosis, hypomania, or maniaHistorical diagnosis of autism spectrum disorder or intellectual disabilityAntiepileptic 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 female participants (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 minutesSuicide attempt by hanging or strangulation (asphyxiation) leading to anoxiaAny personal history of seizure or family history of epilepsyAny metallic implants, fragments, or devicesAny cardiac pacemaker, medication pump, neural stimulator, or other implanted medical deviceRisk for increased intracranial pressure (e.g., history of intracranial mass)History of intracranial surgical procedureAny contraindication to TMS determined by the TMS Adult Safety Screen (TASS)Any contraindication to MRI identified on imaging center screening formAny non-removable hair, head, or neck body modifications that would impede TMS and proper EEG recording
Source: ClinicalTrials.gov (NCT05652153). StuddyBuddy aggregates publicly available trial information.