About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Single-/paired-pulse transcranial magnetic stimulation
Other interventionSingle-/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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
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.
Secondary outcomes
Change in long-interval intracortical inhibition (LICI)
Change in LICI from baseline will be measured for participants who experience new-onset SB during the study (at either 6-month or 12-month visit, as applicable).
Change in negative urgency
Change in negative urgency (on the UPPS-P negative urgency subscale) from baseline will be measured for participants who experience new-onset SB during the study (at either 6-month or 12-month visit, as applicable).
Sponsors and contacts
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University of Minnesota
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator