NCT05652153 · University of Minnesota
Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
What this study is about
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.
View original scientific 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.
Interventions
OTHER
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 measures
Long-interval intracortical inhibition (LICI) - baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Negative urgency - 6 months
Time frame: 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.
Negative urgency - 12 months
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations