Borderline Personality DisorderPhase 1ADEPTNCT07833761
ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder
A Phase 1 study testing Psilocybin and Psilocybin-Assisted Therapy With Dialectical Behavior Therapy in people with Borderline Personality Disorder and Borderline Personality Pathology, run by University of Minnesota at 2 sites in United States.
Trial summary
ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Borderline Personality Pathology, Depressive Symptoms
- What is being tested?
- Psilocybin and Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Phase 1
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed DSM-5 diagnosis of borderline personality disorder using clinical records and measures used in the M Health Fairview DBT program
- Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy
- Age 25 to 65 years
- Able to speak and understand English
- Ability to complete all protocol-required assessment tools without assistance or alteration to copyrighted assessments
- Ability to comply with all study visits
- Stated willingness to comply with all study procedures and avoid changes to current treatments for the duration of the study
- If of childbearing potential, use of an acceptable birth control method, including abstinence
Who cannot join
- Refusal to give informed consent
- History of bipolar affective disorder type I or II, schizophrenia, psychosis, delusions, paranoia, schizoaffective disorder, or substance use disorder within the past 12 months
- First- or second-degree relative with schizophrenia or any other psychotic disorder
- Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS
- History of suicide attempt in the last 6 months
- Comorbid autism
Show all 19Show fewer
- Pregnant or may have reason to believe they are pregnant
- Pre-existing valvular heart disease or pulmonary hypertension
- Active primary PTSD diagnosis
- Psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- Any medical or psychiatric disorder, disease, condition, injury, symptom, or circumstance that may reduce ability to fulfill study requirements, adversely impact data integrity or validity, or pose increased risk during study participation
- Children
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
- Students of the researcher
- Active members of the military or DoD personnel
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
M Health Fairview DBT Program
Minneapolis, Minnesota, 55455
Ziad Nahas, MD, MSCR, 952-525-4505, ipl@umn.edu
M Physicians St. Louis Park Clinic
Saint Louis Park, Minnesota, 55416
Ziad Nahas, MD, MSCR, 952-525-4505, ipl@umn.edu
About this study
Official title: ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy
ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder.
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation.
The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.
Read the detailed description
ADEPT is an open-label proof-of-concept study designed to assess the safety and tolerability of combining psilocybin-assisted therapy with Dialectical Behavior Therapy in participants with borderline personality disorder.
The study will enroll up to 18 participants who have a confirmed DSM-5 diagnosis of borderline personality disorder and are enrolled in the M Health Fairview Dialectical Behavior Therapy program. Participants must have been enrolled in DBT for at least one month and must have consistent attendance in both group and individual therapy.
The study intervention includes two 25 mg doses of psilocybin administered during supervised dosing visits. Three preparation therapy visits will occur before the first dosing visit. The first dosing visit will be followed by three integration therapy visits. A second psilocybin dosing visit will occur approximately 21 days later, followed by three additional integration therapy visits. Participants will complete a final follow-up visit at week 18, approximately 12 weeks after the second dosing visit.
Participants will continue their usual DBT program while enrolled in the study. The M Health Fairview DBT program includes weekly individual therapy, group therapy skills development, and access to phone coaching.
The primary focus of the study is safety and tolerability. Participants will be monitored during and after dosing, and adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging experiences, and psychedelic-related side effects will be assessed. Secondary outcomes will evaluate changes in borderline personality disorder symptoms, emotion regulation, depressive symptoms, quality of life, treatment credibility and expectancy, mystical experience, and continued participation in DBT after psilocybin-assisted therapy.
- Conditions
- Borderline Personality Disorder, Borderline Personality Pathology, Depressive Symptoms, Emotion Dysregulation, Suicidal Ideation
- Being tested
- Psilocybin, Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
- Keywords
- Psilocybin-assisted therapy, DBT, Psilocybin, DBT+PAT, ADEPT, Emotion dysregulation
- Medical subject headings
- Borderline Personality Disorder, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
Participants will receive two 25 mg doses of psilocybin during supervised dosing visits. Each dosing visit will include study therapist support for a minimum of 6 hours, with preparation and integration therapy sessions before and after dosing.
Psilocybin-Assisted Therapy With Dialectical Behavior TherapyBehavioural
Also called DBT + PAT
Participants will continue in the M Health Fairview Dialectical Behavior Therapy program while receiving psilocybin-assisted therapy. The study therapy sequence includes three preparation visits before the first dosing session, three integration visits after the first dosing session, a second dosing session, and three additional integration visits.
| Study group | Role | What they receive |
|---|---|---|
| DBT Plus Psilocybin-Assisted Therapy | Experimental | Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18. Receives: Drug: Psilocybin; Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Severity, and Frequency of Adverse Events
Safety and tolerability will be assessed by the incidence, severity, and frequency of adverse events, treatment-emergent adverse events, and serious adverse events during the study.
Measured: Baseline through final study visit at week 18
Acute Suicidal Ideation After Psilocybin Dosing
Acute suicidal ideation will be assessed after each psilocybin dosing visit using the Modified Scale for Suicidal Ideation and related safety assessments.
Measured: Within 24 hours after each dosing visit
Challenging Experiences After Psilocybin Dosing
Challenging experiences after psilocybin dosing will be assessed using the Challenging Experiences Questionnaire.
Measured: Integration visit 24 hours after each dosing visit
Psilocybin-Related Side Effects
Psilocybin-related side effects will be assessed using the Swiss Psychedelic Side Effects Inventory.
Measured: Integration visit 24 hours after each dosing visit
Percentage of Participants Who Complete the Study
Study retention will be assessed as the percentage of enrolled participants who complete the final study visit at week 18.
Unit: percentage of participants
Measured: Baseline through final study visit at week 18
Percentage of DBT Therapy Sessions Attended
Dialectical Behavior Therapy session attendance will be assessed as the percentage of scheduled DBT therapy sessions attended during study participation.
Unit: Percentage of sessions
Measured: Baseline through final study visit at week 18
Percentage of Study Assessments Completed
Assessment completion will be assessed as the percentage of scheduled study assessments completed during study participation.
Unit: percentage of assessments
Measured: Baseline through final study visit at week 18
Secondary outcomes (11)
Change in Zanarini Rating Scale Score
Borderline personality disorder symptoms will be assessed using the Zanarini Rating Scale. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater borderline personality disorder symptom severity.
Unit: Points
Measured: Baseline to final study visit at week 18
Change in Personality Inventory for DSM-5 Score
Borderline personality disorder symptoms will be assessed using the Zanarini Rating Scale, Personality Inventory for DSM-5, Inventory of Personality Organization, and Difficulties in Emotion Regulation Scale-16.
Measured: Baseline to final study visit at week 18
Change in Difficulties in Emotion Regulation Scale-16 Score
Emotion regulation difficulties will be assessed using the Difficulties in Emotion Regulation Scale-16. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater emotion regulation difficulties.
Unit: Points
Measured: Baseline to final study visit at week 18
Change in Inventory of Personality Organization Score
Personality organization will be assessed using the Inventory of Personality Organization. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater impairment in personality organization.
Unit: Points
Measured: Baseline to final study visit at week 18
Change in Montgomery-Asberg Depression Rating Scale Score
Depressive symptoms will be assessed using the Montgomery-Asberg Depression Rating Scale and Quick Inventory of Depressive Symptomatology.
Unit: Points
Measured: Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quick Inventory of Depressive Symptomatology Score
Depressive symptoms will be assessed using the Quick Inventory of Depressive Symptomatology. Change in score will be assessed from baseline to week 8 after the second dose and 3 months after the last drug dose or at DBT exit. Higher scores indicate greater depressive symptom severity.
Unit: Points
Measured: Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form Score
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater quality of life enjoyment and satisfaction.
Unit: points
Measured: Baseline to final study visit at week 18
Credibility and Expectancy Questionnaire Credibility Score
Treatment credibility will be assessed using the Credibility and Expectancy Questionnaire. Scores will be assessed the day before the first dosing visit and the day before the second dosing visit. Higher scores indicate greater treatment credibility.
Unit: Points
Measured: Day before first dosing and day before second dosing
Credibility and Expectancy Questionnaire Expectancy Score
Treatment expectancy will be assessed using the Credibility and Expectancy Questionnaire. Scores will be assessed the day before the first dosing visit and the day before the second dosing visit. Higher scores indicate greater treatment expectancy.
Unit: Points
Measured: Day before first dosing and day before second dosing
Mystical Experience After Psilocybin Dosing
Mystical experience after psilocybin dosing will be assessed using the Mystical Experience Questionnaire. Higher scores indicate greater intensity of mystical-type experience.
Unit: Points
Measured: Integration visit immediately after each dosing visit
Rate of Continued Participation in Dialectical Behavior Therapy
Continued participation in Dialectical Behavior Therapy after psilocybin-assisted therapy will be assessed as the rate of DBT participation through the final study visit at week 18.
Unit: percentage of scheduled DBT sessions attended
Measured: Through final study visit at week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single-group proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with ongoing Dialectical Behavior Therapy in participants with borderline personality disorder. Participants will receive preparation sessions, two psilocybin dosing sessions, integration sessions, and a final follow-up visit over approximately 18 weeks.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Filament Health Corp.
- Responsible party
- Sponsor
- Investigators
- Ziad Nahas, MD, MSCR, Principal investigator, University of MinnesotaDevin H Hanson, PhD, LP, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833761
- Sponsor's protocol ID
- PSYCH-2026-35016
- Other IDs
- STUDY00029130
- Acronym
- ADEPT
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy
- ClinicalTrials.gov ID
- NCT07833761
- Acronym / sponsor ID
- ADEPT / PSYCH-2026-35016
- Conditions
- Borderline Personality Disorder, Borderline Personality Pathology, Depressive Symptoms, Emotion Dysregulation, Suicidal Ideation
- Keywords
- Psilocybin-assisted therapy, DBT, Psilocybin, DBT+PAT, ADEPT, Emotion dysregulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Filament Health Corp.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Sep 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.
ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder.
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation.
The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.
Detailed description
ADEPT is an open-label proof-of-concept study designed to assess the safety and tolerability of combining psilocybin-assisted therapy with Dialectical Behavior Therapy in participants with borderline personality disorder.
The study will enroll up to 18 participants who have a confirmed DSM-5 diagnosis of borderline personality disorder and are enrolled in the M Health Fairview Dialectical Behavior Therapy program. Participants must have been enrolled in DBT for at least one month and must have consistent attendance in both group and individual therapy.
The study intervention includes two 25 mg doses of psilocybin administered during supervised dosing visits. Three preparation therapy visits will occur before the first dosing visit. The first dosing visit will be followed by three integration therapy visits. A second psilocybin dosing visit will occur approximately 21 days later, followed by three additional integration therapy visits. Participants will complete a final follow-up visit at week 18, approximately 12 weeks after the second dosing visit.
Participants will continue their usual DBT program while enrolled in the study. The M Health Fairview DBT program includes weekly individual therapy, group therapy skills development, and access to phone coaching.
The primary focus of the study is safety and tolerability. Participants will be monitored during and after dosing, and adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging experiences, and psychedelic-related side effects will be assessed. Secondary outcomes will evaluate changes in borderline personality disorder symptoms, emotion regulation, depressive symptoms, quality of life, treatment credibility and expectancy, mystical experience, and continued participation in DBT after psilocybin-assisted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-group proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with ongoing Dialectical Behavior Therapy in participants with borderline personality disorder. Participants will receive preparation sessions, two psilocybin dosing sessions, integration sessions, and a final follow-up visit over approximately 18 weeks.
| Arm | Type | Receives |
|---|---|---|
| DBT Plus Psilocybin-Assisted Therapy | Experimental | Drug: Psilocybin, Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior TherapyParticipants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed DSM-5 diagnosis of borderline personality disorder using clinical records and measures used in the M Health Fairview DBT program
- Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy
- Age 25 to 65 years
- Able to speak and understand English
- Ability to complete all protocol-required assessment tools without assistance or alteration to copyrighted assessments
Key exclusion criteria (19 listed)
- Refusal to give informed consent
- History of bipolar affective disorder type I or II, schizophrenia, psychosis, delusions, paranoia, schizoaffective disorder, or substance use disorder within the past 12 months
- First- or second-degree relative with schizophrenia or any other psychotic disorder
- Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS
- History of suicide attempt in the last 6 months
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 |
|---|---|---|
| PsilocybinAlso: 4-phosphoryloxy-N,N-dimethyltryptamineParticipants will receive two 25 mg doses of psilocybin during supervised dosing visits. Each dosing visit will include study therapist support for a minimum of 6 hours, with preparation and integration therapy sessions before and after dosing. | Drug | DBT Plus Psilocybin-Assisted Therapy |
| Psilocybin-Assisted Therapy With Dialectical Behavior TherapyAlso: DBT + PATParticipants will continue in the M Health Fairview Dialectical Behavior Therapy program while receiving psilocybin-assisted therapy. The study therapy sequence includes three preparation visits before the first dosing session, three integration visits after the first dosing session, a second dosing session, and three additional integration visits. | Behavioural | DBT Plus Psilocybin-Assisted Therapy |
Primary outcome
Incidence, Severity, and Frequency of Adverse Events
Time frame: Baseline through final study visit at week 18
Safety and tolerability will be assessed by the incidence, severity, and frequency of adverse events, treatment-emergent adverse events, and serious adverse events during the study.
Acute Suicidal Ideation After Psilocybin Dosing
Time frame: Within 24 hours after each dosing visit
Acute suicidal ideation will be assessed after each psilocybin dosing visit using the Modified Scale for Suicidal Ideation and related safety assessments.
Challenging Experiences After Psilocybin Dosing
Time frame: Integration visit 24 hours after each dosing visit
Challenging experiences after psilocybin dosing will be assessed using the Challenging Experiences Questionnaire.
Psilocybin-Related Side Effects
Time frame: Integration visit 24 hours after each dosing visit
Psilocybin-related side effects will be assessed using the Swiss Psychedelic Side Effects Inventory.
Percentage of Participants Who Complete the Study
Time frame: Baseline through final study visit at week 18
Study retention will be assessed as the percentage of enrolled participants who complete the final study visit at week 18. Unit: percentage of participants
Percentage of DBT Therapy Sessions Attended
Time frame: Baseline through final study visit at week 18
Dialectical Behavior Therapy session attendance will be assessed as the percentage of scheduled DBT therapy sessions attended during study participation. Unit: Percentage of sessions
Percentage of Study Assessments Completed
Time frame: Baseline through final study visit at week 18
Assessment completion will be assessed as the percentage of scheduled study assessments completed during study participation. Unit: percentage of assessments
11 secondary outcomes
Change in Zanarini Rating Scale Score
Time frame: Baseline to final study visit at week 18
Change in Personality Inventory for DSM-5 Score
Time frame: Baseline to final study visit at week 18
Change in Difficulties in Emotion Regulation Scale-16 Score
Time frame: Baseline to final study visit at week 18
Change in Inventory of Personality Organization Score
Time frame: Baseline to final study visit at week 18
Change in Montgomery-Asberg Depression Rating Scale Score
Time frame: Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quick Inventory of Depressive Symptomatology Score
Time frame: Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form Score
Time frame: Baseline to final study visit at week 18
Credibility and Expectancy Questionnaire Credibility Score
Time frame: Day before first dosing and day before second dosing
Credibility and Expectancy Questionnaire Expectancy Score
Time frame: Day before first dosing and day before second dosing
Mystical Experience After Psilocybin Dosing
Time frame: Integration visit immediately after each dosing visit
Rate of Continued Participation in Dialectical Behavior Therapy
Time frame: Through final study visit at week 18
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 22 Sep 2026.
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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.
Ziad Nahas, MD, MSCR principal investigator
University of Minnesota
Devin H Hanson, PhD, LP study director
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin and Psilocybin-Assisted Therapy With Dialectical Behavior Therapy in people with Borderline Personality Disorder and Borderline Personality Pathology, run by University of Minnesota at 2 sites 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 8 inclusion and 19 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ziad Nahas, MD, MSCR (952-525-4505, znahas@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, Severity, and Frequency of Adverse Events (time frame: Baseline through final study visit at week 18). The study lists 7 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 22 Sep 2026.