DemoralizationEarly Phase 1NCT05227742
Exploratory Study of Low Dose Psilocybin
A Early Phase 1 study testing Psilocybin in people with Demoralization, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Demoralization
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to read and write in English
- Between 25 and 65 years old
- Demoralization Scale-II (DS-II) score of > 8
- No prior hallucinogen use or it would have been 3 years since the last use of a hallucinogen
- Availability of a friend, family member, or other form of transportation (e.g., Uber) to drive participants home after their drug administration sessions
- In good general health as assessed by detailed medical history interview and physical examination
Who cannot join
- 24 years of age or younger; 66 years of age or older
- Women who are pregnant (pregnancy status confirmed via urine pregnancy test) or breastfeeding
- Current hypertension (exceeding 140 systolic and/or 90 diastolic at resting)
- Use of methylphenidate or other medications for ADHD, benzodiazepines or other medications for anxiety (e.g., beta-blockers), tricyclic antidepressants, MAOIs, SSRIs, SNRIs or other medications for depression, lithium or other mood stabilizers, haloperidol or other antipsychotic medications, any medications or supplements with serotonin activity (e.g., St. John's Wort), or any other pharmacologic or biologic agent used to treat depression or anxiety (e.g., magnesium, cannabis)
- Personal or family history (first or second degree relatives) of psychotic or bipolar I or II disorders
- Any suicidal ideation of type 4 or type 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (i.e., active suicidal thought with method and intent but without a specific plan, or active suicidal thought with method, intent and plan).
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- History of head trauma, loss of consciousness, or neurological disease
- Receiving treatment within the past 30 days for depression, anxiety, or substance use disorder
- Participation within the past 30 days in a clinical trial for the treatment of depression, anxiety, or substance use disorder
- Any current substance use disorder diagnosis (substance abstinence confirmed via urine drug screen)
- History of immoderate alcohol consumption within the past 3 months per NIAAA definitions: more than 4 drinks per day or 14 drinks per week for men; more than 3 drinks per day or 7 drinks per week for women
- Any headache disorder (i.e., migraine, tension-type headache, or cluster headache) in the past year
- Planning to move from the Birmingham area in the next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35209
About this study
Official title: Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship).
Read the detailed description
Individuals who call research staff will undergo an initial telephone screen that will determine eligibility.
Week 1: Baseline Intake Appointment. Those who are eligible to participate on the basis of the telephone screen and provide informed consent will then complete a standard demographic questionnaire, a detailed psychiatric interview, and provide a urine sample for confirmation of substance abstinence and pregnancy status. Participants will then be administered a detailed medical history interview and physical examination including EKG and blood panel.
Week 2: Orientation. Participants who are medically eligible to participate will be scheduled for a psychoeducational orientation session that further explains the rationale of the study, and summarizes the study logistics. Participants will complete a number of baseline questionnaires and neuropsychological assessments at this time.
Week 3: Drug administration #1. In a between-groups design, participants will be randomized to receive 0 mg, 1 mg, 2.5 mg, or 5 mg of psilocybin at five weekly 6-hour long drug administration sessions. Dose will remain constant for each participant at each drug administration session.
At Drug Administration #1 and all subsequent drug administration sessions, participants will complete visual analogue scale (VAS) questions drawn from different sources that include drug abuse liability measures. These VAS questions will be administered at drug administration baseline and every 30 minutes thereafter through the end of acute effects at 6-hrs post-baseline. Research staff will complete a number of observational assessments at similar intervals.
Blood pressure will be assessed at regular intervals via automatic blood pressure monitor (i.e., at baseline and at 30, 60, 90, 120, 180, 240, and 360 min post-baseline), and medication for the treatment of acute hypertension will be administered should blood pressure exceed 200 systolic and/or 110 diastolic.
At peak drug effects (2 hr post-baseline), a number of measures will be administered, each differing by drug administration session. At Drug Administration #1, participants will undergo two electroencephalogram (EEG) tasks (with assessments at baseline serving as pre-drug control values).
At 6-hr post-baseline, participants will complete self-report measures assessing the subjective experience. These questionnaires will be administered at the conclusion of each drug administration session. Participants will then be administered a brief semi-structured qualitative interview designed to probe the nature of their experience. All participants will be required to arrange for transportation home from the CRU; participants will not be allowed to drive themselves after drug administration sessions.
Week 4: Drug Administration #2. This session will be identical to Drug Administration #1, however, at peak drug effects, participants will complete two new EEG tasks (with assessments at baseline serving as pre-drug control values).
Week 5: Drug Administration #3. This session will be identical to prior drug administration sessions, however, at peak drug effects, a neuropsychological measure will be administered.
Week 6: Drug Administration #4. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure.
Week 7: Drug Administration #5. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure. At the conclusion of this measure, subjects will undergo an EEG assessment (with an assessment at baseline serving as a pre-drug control value).
Week 8: Study Termination. This session will comprise completion of the same questionnaires that were previously completed at baseline as well as a semi-structured qualitative interview. EKG will be repeated at study termination.
It is noted that over the duration of the study, every day participants will be asked to complete some brief self-report measures and a resting state EEG via a smartphone app.
- Conditions
- Demoralization
- Being tested
- Psilocybin, Placebo
- Keywords
- Psilocybin, Low dose, Demoralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Participants will receive oral psilocybin once per week for 5 weeks.
PlaceboDrug
Participants will receive inert placebo once per week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (0 mg psilocybin) | Placebo comparator | Participants in this arm will receive 0 mg of psilocybin once per week for 5 weeks. Receives: Drug: Placebo |
| 1 mg psilocybin | Experimental | Participants in this arm will receive 1 mg psilocybin once per week for 5 weeks. Receives: Drug: Psilocybin |
| 2.5 mg psilocybin | Experimental | Participants in this arm will receive 2.5 mg psilocybin once per week for 5 weeks. Receives: Drug: Psilocybin |
| 5 mg psilocybin | Experimental | Participants in this arm will receive 5 mg psilocybin once per week for 5 weeks. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demoralization
Demoralization as assessed by the Demoralization Scale-II (DS-II; possible range = 0 to 32, with higher scores reflecting worse outcomes)
Measured: Study Termination at Week 8
Mystical Experience
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Measured: At the conclusion of Drug Administration #1 at Week 3
Mystical Experience
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Measured: At the conclusion of Drug Administration #2 at Week 4
Mystical Experience
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Measured: At the conclusion of Drug Administration #3 at Week 5
Mystical Experience
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Measured: At the conclusion of Drug Administration #4 at Week 6
Mystical Experience
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Measured: At the conclusion of Drug Administration #5 at Week 7
Challenging Experience
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Measured: At the conclusion of Drug Administration #1 at Week 3
Challenging Experience
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Measured: At the conclusion of Drug Administration #2 at Week 4
Challenging Experience
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Measured: At the conclusion of Drug Administration #3 at Week 5
Challenging Experience
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Measured: At the conclusion of Drug Administration #4 at Week 6
Challenging Experience
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Measured: At the conclusion of Drug Administration #5 at Week 7
PASAT
Executive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT)
Measured: At hour 2 of Drug Administration #3 at Week 5
Trail Making
Executive functioning as assessed by the Delis-Kaplan Trail Making Test
Measured: At hour 2 of Drug Administration #4 at Week 6
CPT-3
Attention and cognitive control as assessed by Conner's Continuous Performance Test (CPT-3)
Measured: At hour 2 of Drug Administration #5 at Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Aug 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: Sponsor terminated contract due to insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DemoralizationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo-controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Diamond Therapeutics Inc.
- Responsible party
- Principal investigator, Peter Hendricks, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227742
- Sponsor's protocol ID
- IRB-300008551
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health
- ClinicalTrials.gov ID
- NCT05227742
- Acronym / sponsor ID
- IRB-300008551
- Conditions
- Demoralization
- Keywords
- Psilocybin, Low dose, Demoralization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated contract due to insufficient funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Diamond Therapeutics Inc.
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Feb 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 purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship).
Detailed description
Individuals who call research staff will undergo an initial telephone screen that will determine eligibility.
Week 1: Baseline Intake Appointment. Those who are eligible to participate on the basis of the telephone screen and provide informed consent will then complete a standard demographic questionnaire, a detailed psychiatric interview, and provide a urine sample for confirmation of substance abstinence and pregnancy status. Participants will then be administered a detailed medical history interview and physical examination including EKG and blood panel.
Week 2: Orientation. Participants who are medically eligible to participate will be scheduled for a psychoeducational orientation session that further explains the rationale of the study, and summarizes the study logistics. Participants will complete a number of baseline questionnaires and neuropsychological assessments at this time.
Week 3: Drug administration #1. In a between-groups design, participants will be randomized to receive 0 mg, 1 mg, 2.5 mg, or 5 mg of psilocybin at five weekly 6-hour long drug administration sessions. Dose will remain constant for each participant at each drug administration session.
At Drug Administration #1 and all subsequent drug administration sessions, participants will complete visual analogue scale (VAS) questions drawn from different sources that include drug abuse liability measures. These VAS questions will be administered at drug administration baseline and every 30 minutes thereafter through the end of acute effects at 6-hrs post-baseline. Research staff will complete a number of observational assessments at similar intervals.
Blood pressure will be assessed at regular intervals via automatic blood pressure monitor (i.e., at baseline and at 30, 60, 90, 120, 180, 240, and 360 min post-baseline), and medication for the treatment of acute hypertension will be administered should blood pressure exceed 200 systolic and/or 110 diastolic.
At peak drug effects (2 hr post-baseline), a number of measures will be administered, each differing by drug administration session. At Drug Administration #1, participants will undergo two electroencephalogram (EEG) tasks (with assessments at baseline serving as pre-drug control values).
At 6-hr post-baseline, participants will complete self-report measures assessing the subjective experience. These questionnaires will be administered at the conclusion of each drug administration session. Participants will then be administered a brief semi-structured qualitative interview designed to probe the nature of their experience. All participants will be required to arrange for transportation home from the CRU; participants will not be allowed to drive themselves after drug administration sessions.
Week 4: Drug Administration #2. This session will be identical to Drug Administration #1, however, at peak drug effects, participants will complete two new EEG tasks (with assessments at baseline serving as pre-drug control values).
Week 5: Drug Administration #3. This session will be identical to prior drug administration sessions, however, at peak drug effects, a neuropsychological measure will be administered.
Week 6: Drug Administration #4. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure.
Week 7: Drug Administration #5. This session will be identical to prior drug administration sessions, however, at peak drug effects, participants will complete another neuropsychological measure. At the conclusion of this measure, subjects will undergo an EEG assessment (with an assessment at baseline serving as a pre-drug control value).
Week 8: Study Termination. This session will comprise completion of the same questionnaires that were previously completed at baseline as well as a semi-structured qualitative interview. EKG will be repeated at study termination.
It is noted that over the duration of the study, every day participants will be asked to complete some brief self-report measures and a resting state EEG via a smartphone app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo (0 mg psilocybin) | Placebo comparator | Drug: PlaceboParticipants in this arm will receive 0 mg of psilocybin once per week for 5 weeks. |
| 1 mg psilocybin | Experimental | Drug: PsilocybinParticipants in this arm will receive 1 mg psilocybin once per week for 5 weeks. |
| 2.5 mg psilocybin | Experimental | Drug: PsilocybinParticipants in this arm will receive 2.5 mg psilocybin once per week for 5 weeks. |
| 5 mg psilocybin | Experimental | Drug: PsilocybinParticipants in this arm will receive 5 mg psilocybin once per week for 5 weeks. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to read and write in English
- Between 25 and 65 years old
- Demoralization Scale-II (DS-II) score of > 8
- No prior hallucinogen use or it would have been 3 years since the last use of a hallucinogen
- Availability of a friend, family member, or other form of transportation (e.g., Uber) to drive participants home after their drug administration sessions
Key exclusion criteria (13 listed)
- 24 years of age or younger; 66 years of age or older
- Women who are pregnant (pregnancy status confirmed via urine pregnancy test) or breastfeeding
- Current hypertension (exceeding 140 systolic and/or 90 diastolic at resting)
- Use of methylphenidate or other medications for ADHD, benzodiazepines or other medications for anxiety (e.g., beta-blockers), tricyclic antidepressants, MAOIs, SSRIs, SNRIs or other medications for depression, lithium or other mood stabilizers, haloperidol or other antipsychotic medications, any medications or supplements with serotonin activity (e.g., St. John's Wort), or any other pharmacologic or biologic agent used to treat depression or anxiety (e.g., magnesium, cannabis)
- Personal or family history (first or second degree relatives) of psychotic or bipolar I or II disorders
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 |
|---|---|---|
| PsilocybinParticipants will receive oral psilocybin once per week for 5 weeks. | Drug | 1 mg psilocybin, 2.5 mg psilocybin, 5 mg psilocybin |
| PlaceboParticipants will receive inert placebo once per week for 5 weeks. | Drug | Placebo (0 mg psilocybin) |
Primary outcome
Demoralization
Time frame: Study Termination at Week 8
Demoralization as assessed by the Demoralization Scale-II (DS-II; possible range = 0 to 32, with higher scores reflecting worse outcomes)
Mystical Experience
Time frame: At the conclusion of Drug Administration #1 at Week 3
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Mystical Experience
Time frame: At the conclusion of Drug Administration #2 at Week 4
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Mystical Experience
Time frame: At the conclusion of Drug Administration #3 at Week 5
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Mystical Experience
Time frame: At the conclusion of Drug Administration #4 at Week 6
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Mystical Experience
Time frame: At the conclusion of Drug Administration #5 at Week 7
Mystical experience as assessed by the Mystical Experience Questionnaire (MEQ; possible range = 0 to 5, with higher scores reflecting more mystical experience)
Challenging Experience
Time frame: At the conclusion of Drug Administration #1 at Week 3
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Challenging Experience
Time frame: At the conclusion of Drug Administration #2 at Week 4
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Challenging Experience
Time frame: At the conclusion of Drug Administration #3 at Week 5
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Challenging Experience
Time frame: At the conclusion of Drug Administration #4 at Week 6
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
Challenging Experience
Time frame: At the conclusion of Drug Administration #5 at Week 7
Challenging experience as assessed by the Challenging Experience Questionnaire (CEQ; possible range = 0=5, with higher scores reflection more challenging experiences)
PASAT
Time frame: At hour 2 of Drug Administration #3 at Week 5
Executive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT)
Trail Making
Time frame: At hour 2 of Drug Administration #4 at Week 6
Executive functioning as assessed by the Delis-Kaplan Trail Making Test
CPT-3
Time frame: At hour 2 of Drug Administration #5 at Week 7
Attention and cognitive control as assessed by Conner's Continuous Performance Test (CPT-3)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin in people with Demoralization, run by University of Alabama at Birmingham 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 11 Mar 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demoralization (time frame: Study Termination at Week 8). The study lists 14 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 11 Mar 2026.