Major Depressive DisorderCAREDNCT07507370
CARED : A Novel Rapid Treatment Paradigm for Depression
A study testing Intermittent Theta Burst Stimulation (iTBS), Transcranial Alternating Current Stimulation (tACS) and Psychotherapy in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Intermittent Theta Burst Stimulation (iTBS), Transcranial Alternating Current Stimulation (tACS) and Psychotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 1 Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender, aged 18 - 70
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND)
- HDRS-17 score ≥14
- Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the Columbia-Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
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- Capacity to understand all relevant risks and potential benefits of the study (informed consent).
- For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation
- History of treatment resistance as indicated by previously or currently not achieving clinically significant symptom reduction on at least one antidepressant medication. This will be evaluated using the Maudsley Treatment Inventory (MTI). Participants with scores greater than or equal to 3 on the MTI will be included.
Who cannot join
- DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
- DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
- Lifetime history of bipolar disorder, as evidenced by DIAMOND
- Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
- History of autism spectrum disorder (self-reported by participants)
- Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks
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- Initiated a new course of psychotherapy in the 6 weeks preceding screening
- Received any neurostimulation treatment in the 6 weeks preceding screening
- History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)
- Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation)
- Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)
- Prior brain surgery and/or brain implants
- Personal or familia history of epilepsy
- Previous fainting spells or syncope
- Metal in the brain, skull or elsewhere in the body
- Implanted medical device that uses electricity and any implanted devices in other areas of the head or neck, or implants located < 30cm from the position of the TMS coil
- Current pregnancy or lactation
- Currently enrolled in another clinical trial for depression
- Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator
- Non-English speaking individuals are excluded because the ability to accurately and completely communicate study information, answer questions about the study, and obtain consent in the English language are necessary, and due to resource constraints it is not feasible to engage an interpreter for language services.
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
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
Flavio Frohlich, PhD, 919-966-9929, flavio_frohlich@med.unc.edu
About this study
Official title: The Carolina Recovery From Depression Protocol (CARED) : A Novel Rapid Treatment Paradigm for Depression
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).
Read the detailed description
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). Investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical interventions for Major Depressive Disorder. In this trial, participants will receive 3 interventions in a single session: psychotherapy, Intermittent Theta Burst Stimulation (iTBS), and participants will be randomized to receive either active or placebo Transcranial Alternating Current Stimulation (tACS). Additionally, Clinical assessments of depression symptoms are performed at Screening (for eligibility), Baseline (at start of day, prior to any intervention), Follow up 1 (FUP1); 2 weeks after SSI) and Follow up 2 (FUP2; 3 months after SSI). Additional assessments of anxiety symptoms, emotion regulation, clinical improvement and quality of life are included.
Primary Objective:
- Establish the safety, feasibility, and tolerability of the SSI
Second Objective:
- Establish the efficacy of the SSI for the treatment of depression symptoms by determining symptom reduction 2 weeks after completion of SSI.
- Determine whether the combined effect of psychotherapy, TMS and tACS for treating depression reduces symptoms above and beyond TMS and therapy alone at FUP1.
- Determine the longevity of intervention effectiveness (if effective) via follow up (FUP) timepoints for both groups and between groups by comparing scores at FUP1 to scores at FUP2
- Conditions
- Major Depressive Disorder
- Being tested
- Intermittent Theta Burst Stimulation (iTBS), Transcranial Alternating Current Stimulation (tACS), Psychotherapy, Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)
- Keywords
- Non-invasive Brain Stimulation, Psychotherapy, Transcranial Magnetic Stimulation, Single Session Intervention, tACS, Behavioral Activation, Depression, Transcranial Alternating Current Stimulation, Acceptance and Commitment Therapy, Mood Disorders, Brief Intervention, TMS, Neurostimulation
- Medical subject headings
- Depressive Disorder, Major, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Stimulation (iTBS)Device
The TMS stimulation will be delivered using the MagPro X100 system (MagVenture Inc., Alpharetta, Georgia, USA). Participants will receive theta-burst stimulation (iTBS) consisting of 1,800 biphasic pulses delivered in bursts of three pulses at 50 Hz, repeated at 5 Hz (2-s trains, 8-s inter-train interval, 30 trains total per block), at an intensity of 90 % of the resting motor threshold. TMS will be delivered before each tACS/therapy block (over the tACS electrodes), totaling 5 blocks of TMS throughout the single session intervention.
Transcranial Alternating Current Stimulation (tACS)Device
Also called NeuroConn DC Stimulator MC, NeuroConn LOOP-IT
The alpha and -theta tACS stimulation will be delivered using the neuroConn DC Stimulator MC.The interventional tACS stimulation will be 120 minutes of tACS total; 60 minutes will be delivered during the second block of therapy and 60 minutes will be delivered during the third block of therapy.F3 and F4 will be stimulated 'in-phase', with 1 mA applied at each location, and Cz will be stimulated 'anti-phase' with 2mA applied (zero to peak). tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab.
PsychotherapyBehavioural
The three, 1-hour psychotherapy blocks were designed to incorporate effective components from multiple psychotherapies, with an emphasis on functional analysis to define the presenting concern, followed by Behavioral Activation (BA) and Acceptance and Commitment Therapy modules to target low mood and psychological flexibility, respectively.
The SSI was designed to incorporate ACT principles throughout the modules, guided by the tenets of psychological flexibility, as described by Hayes. Be present, open up, do what matters. The manual was created by a team of several advanced clinical trainees and two licensed clinical psychologists. The last 10 minutes of each session will be spent briefly reviewing the day's activities, what stood out for participants (negative or positive), and whether they had feedback for the clinician.
Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)Device
Participants will be fitted with the same tACS setup and will receive sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current (20 second ramp up and ramp down; total 80 seconds of stimulation). This active sham is designed to mimic the sensation of receiving stimulation without delivering a sufficient dose of tACS to influence the efficacy of the SSI.
| Study group | Role | What they receive |
|---|---|---|
| Inactive Sham (Placebo) | Active comparator | Participants will receive psychotherapy, active iTBS, and sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current. The sham is designed to mimic the sensation of receiving Alpha and Theta tACS without delivering a sufficient dose. Receives: Device: Intermittent Theta Burst Stimulation (iTBS); Behavioral: Psychotherapy; Device: Sham (Placebo) Transcranial Alternating Current Stimulation (tACS) |
| Active tACS: Experimental Arm | Experimental | Participants will receive psychotherapy, active iTBS, and active tACS in which alpha-theta tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation followed by 2 mA between the stimulation sites. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab Receives: Device: Intermittent Theta Burst Stimulation (iTBS); Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety via the presence of any serious AEs
The number of serious adverse events (SAEs) determined to be related to intervention in both experimental and sham arms.
Measured: Day 0 (Baseline) to Day 90 (Follow-up 2)
Feasibility of the Single Session Intervention
Number of enrolled participants who successfully complete the intervention session.
Measured: Day 0 (Baseline)
Secondary outcomes (2)
Change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.
The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 0 (Baseline) to Day 14 (Follow-up 1).
Measured: Day 1 (Baseline) to Day 14 (Follow-up 1)
Duration of change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.
The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores between Day 14 (Follow Up 1) to Day 90 (Follow-up 2) to establish the longevity of treatment effectiveness (if effective) via Follow Up timepoints overall and for both arms.
Measured: Day 14 (Follow Up 1) to Day 90 (Follow-up 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start14 Apr 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design is a parallel arm design in which participants will be randomly assigned to either active tACS psychotherapy and iTBS or assigned to sham (placebo) tACS with psychotherapy and iTBS. Psychotherapeutic and iTBS interventions will be active interventions in both arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507370
- Sponsor's protocol ID
- 26-0141
- Acronym
- CARED
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Carolina Recovery From Depression Protocol (CARED) : A Novel Rapid Treatment Paradigm for Depression
- ClinicalTrials.gov ID
- NCT07507370
- Acronym / sponsor ID
- CARED / 26-0141
- Conditions
- Major Depressive Disorder
- Keywords
- Non-invasive Brain Stimulation, Psychotherapy, Transcranial Magnetic Stimulation, Single Session Intervention, tACS, Behavioral Activation, Depression, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Apr 2026 (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 purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).
Detailed description
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). Investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical interventions for Major Depressive Disorder. In this trial, participants will receive 3 interventions in a single session: psychotherapy, Intermittent Theta Burst Stimulation (iTBS), and participants will be randomized to receive either active or placebo Transcranial Alternating Current Stimulation (tACS). Additionally, Clinical assessments of depression symptoms are performed at Screening (for eligibility), Baseline (at start of day, prior to any intervention), Follow up 1 (FUP1); 2 weeks after SSI) and Follow up 2 (FUP2; 3 months after SSI). Additional assessments of anxiety symptoms, emotion regulation, clinical improvement and quality of life are included.
Primary Objective:
- Establish the safety, feasibility, and tolerability of the SSI
Second Objective:
- Establish the efficacy of the SSI for the treatment of depression symptoms by determining symptom reduction 2 weeks after completion of SSI.
- Determine whether the combined effect of psychotherapy, TMS and tACS for treating depression reduces symptoms above and beyond TMS and therapy alone at FUP1.
- Determine the longevity of intervention effectiveness (if effective) via follow up (FUP) timepoints for both groups and between groups by comparing scores at FUP1 to scores at FUP2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study design is a parallel arm design in which participants will be randomly assigned to either active tACS psychotherapy and iTBS or assigned to sham (placebo) tACS with psychotherapy and iTBS. Psychotherapeutic and iTBS interventions will be active interventions in both arms.
| Arm | Type | Receives |
|---|---|---|
| Inactive Sham (Placebo) | Active comparator | Device: Intermittent Theta Burst Stimulation (iTBS), Behavioral: Psychotherapy, Device: Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)Participants will receive psychotherapy, active iTBS, and sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current. The sham is designed to mimic the sensation of receiving Alpha and Theta tACS without delivering a sufficient dose. |
| Active tACS: Experimental Arm | Experimental | Device: Intermittent Theta Burst Stimulation (iTBS), Device: Transcranial Alternating Current Stimulation (tACS), Behavioral: PsychotherapyParticipants will receive psychotherapy, active iTBS, and active tACS in which alpha-theta tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation followed by 2 mA between the stimulation sites. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Any gender, aged 18 - 70
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND)
- HDRS-17 score ≥14
Key exclusion criteria (20 listed)
- DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
- DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
- Lifetime history of bipolar disorder, as evidenced by DIAMOND
- Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
- History of autism spectrum disorder (self-reported by participants)
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 |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS)The TMS stimulation will be delivered using the MagPro X100 system (MagVenture Inc., Alpharetta, Georgia, USA). Participants will receive theta-burst stimulation (iTBS) consisting of 1,800 biphasic pulses delivered in bursts of three pulses at 50 Hz, repeated at 5 Hz (2-s trains, 8-s inter-train interval, 30 trains total per block), at an intensity of 90 % of the resting motor threshold. TMS will be delivered before each tACS/therapy block (over the tACS electrodes), totaling 5 blocks of TMS throughout the single session intervention. | Device | Active tACS: Experimental Arm, Inactive Sham (Placebo) |
| Transcranial Alternating Current Stimulation (tACS)Also: NeuroConn DC Stimulator MC, NeuroConn LOOP-ITThe alpha and -theta tACS stimulation will be delivered using the neuroConn DC Stimulator MC.The interventional tACS stimulation will be 120 minutes of tACS total; 60 minutes will be delivered during the second block of therapy and 60 minutes will be delivered during the third block of therapy.F3 and F4 will be stimulated 'in-phase', with 1 mA applied at each location, and Cz will be stimulated 'anti-phase' with 2mA applied (zero to peak). tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab. | Device | Active tACS: Experimental Arm |
| PsychotherapyThe three, 1-hour psychotherapy blocks were designed to incorporate effective components from multiple psychotherapies, with an emphasis on functional analysis to define the presenting concern, followed by Behavioral Activation (BA) and Acceptance and Commitment Therapy modules to target low mood and psychological flexibility, respectively. The SSI was designed to incorporate ACT principles throughout the modules, guided by the tenets of psychological flexibility, as described by Hayes. Be present, open up, do what matters. The manual was created by a team of several advanced clinical trainees and two licensed clinical psychologists. The last 10 minutes of each session will be spent briefly reviewing the day's activities, what stood out for participants (negative or positive), and whether they had feedback for the clinician. | Behavioural | Active tACS: Experimental Arm, Inactive Sham (Placebo) |
| Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)Participants will be fitted with the same tACS setup and will receive sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current (20 second ramp up and ramp down; total 80 seconds of stimulation). This active sham is designed to mimic the sensation of receiving stimulation without delivering a sufficient dose of tACS to influence the efficacy of the SSI. | Device | Inactive Sham (Placebo) |
Primary outcome
Safety via the presence of any serious AEs
Time frame: Day 0 (Baseline) to Day 90 (Follow-up 2)
The number of serious adverse events (SAEs) determined to be related to intervention in both experimental and sham arms.
Feasibility of the Single Session Intervention
Time frame: Day 0 (Baseline)
Number of enrolled participants who successfully complete the intervention session.
2 secondary outcomes
Change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.
Time frame: Day 1 (Baseline) to Day 14 (Follow-up 1)
Duration of change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.
Time frame: Day 14 (Follow Up 1) to Day 90 (Follow-up 2)
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 25 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable
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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.
Flavio Frohlich, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation (iTBS), Transcranial Alternating Current Stimulation (tACS) and Psychotherapy in people with Major Depressive Disorder, run by University of North Carolina, Chapel Hill 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 9 inclusion and 20 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 25 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 Flavio Frohlich, PhD (919-966-9929, flavio_frohlich@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety via the presence of any serious AEs (time frame: Day 0 (Baseline) to Day 90 (Follow-up 2)). The study lists 2 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 25 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.