Suicidal BehaviorNCT05652153
Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
A study testing Single-/paired-pulse transcranial magnetic stimulation in people with Suicidal Behavior and Suicidal Ideation, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Suicidal Behavior, Suicidal Ideation, Negative Urgency
- What is being tested?
- Single-/paired-pulse transcranial magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Charles Lewis
About this study
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:
Read more
- 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
Read the detailed description
This project will study the neural underpinnings of impulsivity in adolescent suicidal behavior (SB). Suicide is the second leading cause of death in adolescence, and rates of adolescent SB are increasing. However, its neurobiology remains poorly understood, and treatments specifically targeting SB are lacking. SB in adolescents is a critical public health problem that demands urgent attention, particularly with research that will rapidly translate knowledge to clinical applications. Negative urgency, a component of impulsivity, is the tendency to act rashly in the context of negative emotion. It has been found to be increased among youth with SB and suicide attempts, and has been linked to impaired inhibition of limbic circuitry by the dorsolateral prefrontal cortex (DLPFC), yet precise mechanisms are unclear. Transcranial magnetic stimulation (TMS) permits noninvasive quantification of DLPFC functions such as cortical inhibition (CI), the process by which cortical interneurons regulate the activity of other circuits. Previous research indicates that adolescents with lifetime SB have reduced CI in the motor cortex that distinguishes them from non-suicidal youth. However, DLPFC CI has not been measured in adolescents with SB, nor is it clear how CI relates to cognitive and emotional systems implicated in SB, such as negative urgency. In order to study CI-related mechanisms of negative urgency in the DLPFC, simultaneous TMS and electroencephalography (TMS-EEG) is required. This is a longitudinal study of inhibitory physiology and negative urgency in 40 depressed adolescents with suicidal ideation (but no prior SB) and 40 depressed adolescents with SB. The study will utilize TMS-EEG and self-report measures of negative urgency to test hypotheses that dysregulated CI is associated with negative urgency, that DLPFC CI is deficient in adolescents with SB, and that CI deficits correlate longitudinally with changes in negative urgency and newly emergent SB. The long-term goal of this research is to utilize data gathered in this project to design a large-scale longitudinal study assessing neural and behavioral risk factors for developing SB, as well as trials of neuromodulatory treatments that will reduce the transition from suicidal thoughts to behaviors by targeting alterations in CI and negative urgency.
- Being tested
- Single-/paired-pulse transcranial magnetic stimulation
- Keywords
- Suicidal Behavior, Suicidal Ideation, Negative Urgency, Cortical Inhibition, Depression, Adolescent, Transcranial Magnetic Stimulation, Electroencephalography
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-/paired-pulse transcranial magnetic stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Single-/paired-pulse transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 6 months or 12 months
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).
Measured: 6 months or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start25 May 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kathryn Cullen, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652153
- Sponsor's protocol ID
- PSYCH-2023-31353
- Other IDs
- 1K23MH127307
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior
- ClinicalTrials.gov ID
- NCT05652153
- Acronym / sponsor ID
- PSYCH-2023-31353
- Keywords
- Suicidal Behavior, Suicidal Ideation, Negative Urgency, Cortical Inhibition, Depression, Adolescent, Transcranial Magnetic Stimulation, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 May 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This project will study the neural underpinnings of impulsivity in adolescent suicidal behavior (SB). Suicide is the second leading cause of death in adolescence, and rates of adolescent SB are increasing. However, its neurobiology remains poorly understood, and treatments specifically targeting SB are lacking. SB in adolescents is a critical public health problem that demands urgent attention, particularly with research that will rapidly translate knowledge to clinical applications. Negative urgency, a component of impulsivity, is the tendency to act rashly in the context of negative emotion. It has been found to be increased among youth with SB and suicide attempts, and has been linked to impaired inhibition of limbic circuitry by the dorsolateral prefrontal cortex (DLPFC), yet precise mechanisms are unclear. Transcranial magnetic stimulation (TMS) permits noninvasive quantification of DLPFC functions such as cortical inhibition (CI), the process by which cortical interneurons regulate the activity of other circuits. Previous research indicates that adolescents with lifetime SB have reduced CI in the motor cortex that distinguishes them from non-suicidal youth. However, DLPFC CI has not been measured in adolescents with SB, nor is it clear how CI relates to cognitive and emotional systems implicated in SB, such as negative urgency. In order to study CI-related mechanisms of negative urgency in the DLPFC, simultaneous TMS and electroencephalography (TMS-EEG) is required. This is a longitudinal study of inhibitory physiology and negative urgency in 40 depressed adolescents with suicidal ideation (but no prior SB) and 40 depressed adolescents with SB. The study will utilize TMS-EEG and self-report measures of negative urgency to test hypotheses that dysregulated CI is associated with negative urgency, that DLPFC CI is deficient in adolescents with SB, and that CI deficits correlate longitudinally with changes in negative urgency and newly emergent SB. The long-term goal of this research is to utilize data gathered in this project to design a large-scale longitudinal study assessing neural and behavioral risk factors for developing SB, as well as trials of neuromodulatory treatments that will reduce the transition from suicidal thoughts to behaviors by targeting alterations in CI and negative urgency.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Assessments | Other | Other: Single-/paired-pulse transcranial magnetic stimulationParticipants 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-/paired-pulse transcranial magnetic stimulationSingle-/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. | Other | Longitudinal Assessments |
Primary outcome
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.
2 secondary outcomes
Change in long-interval intracortical inhibition (LICI)
Time frame: 6 months or 12 months
Change in negative urgency
Time frame: 6 months or 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Cullen, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-/paired-pulse transcranial magnetic stimulation in people with Suicidal Behavior and Suicidal Ideation, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles P Lewis, MD (612-625-4081, lewi1538@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-interval intracortical inhibition (LICI) - baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.