AmblyopiaPhase 1/2PATCHNCT07920081
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
A Phase 1/2 study testing Amblyopia Therapy, 1 mg Psilocybin and 5 mg Psilocybin in people with Amblyopia, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Amblyopia Therapy, 1 mg Psilocybin and 5 mg Psilocybin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English
- Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, medical history and physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- Women who are of child-bearing potential and sexually active agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g. coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.
Show all 13Show fewer
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
- Agree not to take any as needed (PRN) medications on the mornings of drug sessions
- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
- Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Have a clinical diagnosis of amblyopia, with best-corrected visual acuity in the range of 0.2 - 1.0 LogMAR (approximately equivalent to 20/30 to 20/200)
- Has undergone an eye exam and prescription assessment within a recent period
- Has been wearing current spectacle correction for a minimum of six weeks prior to enrollment
Who cannot join
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of birth control (i.e. those that result in <1% failure rate per year; note that condoms alone are not considered highly effective)
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation), artificial heart valve, or transient ischemic attack (TIA) in the past year
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Currently taking on a regular (e.g. daily) basis any medications having a primary centrally-acting serotonergic effect, including monoamine oxidase inhibitor (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.
- Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)
Show all 10Show fewer
- Current or past history within the last five years of meeting DSM-5 criteria for a severe alcohol or drug use disorder (excluding caffeine and nicotine)
- Have a first-degree relative with bipolar I disorder, schizophrenia spectrum, or other psychotic disorders (except substance/medication-induced or due to another medical condition)
- Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- Explanation for visual acuity loss other than amblyopia, including cataracts, corneal disease, optic neuropathy, retinopathy, glaucoma, history of eye trauma or intraocular surgery, or any other ocular pathology as determined by study ophthalmologist
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
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
Brian Winston, 410-550-2253, bwinsto2@jh.edu
Frederick S. Barrett, PhD
About this study
Official title: Psilocybin for Amblyopia - Targeting Critical Periods in Humans (PATCH)
The purpose of this study is to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms. It can be ingested orally and can result in strong but short-term (4-6 hours) effects such as changes in perception, thoughts, and emotions.
Read the detailed description
Participation in this study involves up to 12 visits over 9-13 weeks, including a screening visit, a preparation visit, two all-day experimental drug administration sessions with psilocybin, and eight follow up visits.The purpose of these follow-up visits is to deliver in-lab amblyopia therapy, measure visual function, and monitor safety. Participants will also be asked to complete amblyopia therapy at home: this will involve wearing an eyepatch or an eyeglasses filter over the non-amblyopic eye every day for up to several hours and completing online training exercises.
- Conditions
- Amblyopia
- Being tested
- Amblyopia Therapy, 1 mg Psilocybin, 5 mg Psilocybin, 10 mg Psilocybin, 15 mg Psilocybin
- Keywords
- lazy eye, psilocybin, amblyopia, anisometropia, refractive amblyopia, anisometropic amblyopia, psychedelic
- Medical subject headings
- Amblyopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amblyopia TherapyBehavioural
May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning
1 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 1 mg of psilocybin.
5 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 5 mg of psilocybin.
10 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 10 mg of psilocybin.
15 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 15 mg of psilocybin.
20 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 20 mg of psilocybin.
25 mg PsilocybinDrug
The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin.
| Study group | Role | What they receive |
|---|---|---|
| 1 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 1 mg Psilocybin |
| 5 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 5 mg Psilocybin |
| 10 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 10 mg Psilocybin |
| 15 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 15 mg Psilocybin |
| 20 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 20 mg Psilocybin |
| 25 mg Psilocybin with Amblyopia Therapy | Experimental | Not described Receives: Behavioral: Amblyopia Therapy; Drug: 25 mg Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amblyopic Eye Visual Acuity
Measured using LogMAR scale
Measured: from Baseline to two weeks after experimental drug session 2
Change in Fellow Eye Visual Acuity
Measured using LogMAR scale
Measured: from Baseline to two weeks after experimental drug session 2
Secondary outcomes (5)
Challenging Experiences Questionnaire (CEQ)
The Challenging Experience Questionnaire (CEQ) is a self-report measure designed to assess the intensity and quality of difficult or distressing experiences during psychedelic states. Score range 0-5, 0 is equivalent to no challenging experiences and 5 is an extreme (more than ever before in my life). Higher score "more difficult."
Measured: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
11-Dimensional Altered States of Consciousness Questionnaire (11D-ASC)
The 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods. The 11 dimensions are: 1) Experience of Unity, (2) Spiritual Experience, (3) Blissful State, (4) Insightfulness, (5) Disembodiment, (6) Impaired Control and Cognition, (7) Anxiety, (8) Complex Imagery, (9) Elementary Imagery, (10) Audio-Visual Synesthesia, and (11) Changed Meaning of Percepts. Each item is rated on a visual analog scale from 0 to 100, and scores for each dimension are calculated as the mean of the corresponding items, ranging from 0 to 100. Higher scores indicate greater intensity of the respective subjective experience, rather than a uniformly better or worse outcome.
Measured: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
The World Health Organization-Five Well-Being Index (WHO-5)
The WHO-5 is a five-item self-report measure of mental well-being over the preceding two weeks. Each item is scored from 0 to 5, yielding a raw total score ranging from 0 to 25. The raw score can be multiplied by four to obtain a percentage score ranging from 0 to 100. Higher scores indicate better mental well-being.
Measured: At the preparation session, one and two weeks after the first experimental drug administration session, and one, two, and eight weeks after the second drug administration session.
Amblyopia and Strabismus Questionnaire: English (ASQE)
The ASQE is a 26-item self-report questionnaire assessing vision-related quality of life in adults with amblyopia and strabismus. Item responses are converted to scores ranging from 0 to 100, and the total score is calculated as the mean of the item scores, ranging from 0 to 100. Higher scores indicate better vision-related quality of life, with 0 representing the worst and 100 the best possible outcome.
Measured: At the preparation session, two weeks after the first experimental drug administration session, and two and eight weeks after the second experimental drug administration session
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) is a patient-rated questionnaire assessing functional impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is rated on an 11-point scale from 0 (no impairment) to 10 (extreme impairment). The three domain scores are summed to yield a total score ranging from 0 to 30. Higher scores indicate greater functional impairment (worse functioning), while lower scores indicate less impairment (better functioning).
Measured: At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick Barrett, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920081
- Sponsor's protocol ID
- IRB00519391
- Acronym
- PATCH
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin for Amblyopia - Targeting Critical Periods in Humans (PATCH)
- ClinicalTrials.gov ID
- NCT07920081
- Acronym / sponsor ID
- PATCH / IRB00519391
- Conditions
- Amblyopia
- Keywords
- lazy eye, psilocybin, amblyopia, anisometropia, refractive amblyopia, anisometropic amblyopia, psychedelic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Nov 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 evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms. It can be ingested orally and can result in strong but short-term (4-6 hours) effects such as changes in perception, thoughts, and emotions.
Detailed description
Participation in this study involves up to 12 visits over 9-13 weeks, including a screening visit, a preparation visit, two all-day experimental drug administration sessions with psilocybin, and eight follow up visits.The purpose of these follow-up visits is to deliver in-lab amblyopia therapy, measure visual function, and monitor safety. Participants will also be asked to complete amblyopia therapy at home: this will involve wearing an eyepatch or an eyeglasses filter over the non-amblyopic eye every day for up to several hours and completing online training exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 1 mg Psilocybin |
| 5 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 5 mg Psilocybin |
| 10 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 10 mg Psilocybin |
| 15 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 15 mg Psilocybin |
| 20 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 20 mg Psilocybin |
| 25 mg Psilocybin with Amblyopia Therapy | Experimental | Behavioral: Amblyopia Therapy, Drug: 25 mg Psilocybin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 to 65 years old
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English
- Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, medical history and physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- Women who are of child-bearing potential and sexually active agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study
Key exclusion criteria (10 listed)
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of birth control (i.e. those that result in <1% failure rate per year; note that condoms alone are not considered highly effective)
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation), artificial heart valve, or transient ischemic attack (TIA) in the past year
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Currently taking on a regular (e.g. daily) basis any medications having a primary centrally-acting serotonergic effect, including monoamine oxidase inhibitor (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.
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 |
|---|---|---|
| Amblyopia TherapyMay include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning | Behavioural | 1 mg Psilocybin with Amblyopia Therapy, 10 mg Psilocybin with Amblyopia Therapy, 15 mg Psilocybin with Amblyopia Therapy, 20 mg Psilocybin with Amblyopia Therapy, 25 mg Psilocybin with Amblyopia Therapy, 5 mg Psilocybin with Amblyopia Therapy |
| 1 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 1 mg of psilocybin. | Drug | 1 mg Psilocybin with Amblyopia Therapy |
| 5 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 5 mg of psilocybin. | Drug | 5 mg Psilocybin with Amblyopia Therapy |
| 10 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 10 mg of psilocybin. | Drug | 10 mg Psilocybin with Amblyopia Therapy |
| 15 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 15 mg of psilocybin. | Drug | 15 mg Psilocybin with Amblyopia Therapy |
| 20 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 20 mg of psilocybin. | Drug | 20 mg Psilocybin with Amblyopia Therapy |
| 25 mg PsilocybinThe psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin. | Drug | 25 mg Psilocybin with Amblyopia Therapy |
Primary outcome
Change in Amblyopic Eye Visual Acuity
Time frame: from Baseline to two weeks after experimental drug session 2
Measured using LogMAR scale
Change in Fellow Eye Visual Acuity
Time frame: from Baseline to two weeks after experimental drug session 2
Measured using LogMAR scale
5 secondary outcomes
Challenging Experiences Questionnaire (CEQ)
Time frame: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
11-Dimensional Altered States of Consciousness Questionnaire (11D-ASC)
Time frame: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
The World Health Organization-Five Well-Being Index (WHO-5)
Time frame: At the preparation session, one and two weeks after the first experimental drug administration session, and one, two, and eight weeks after the second drug administration session.
Amblyopia and Strabismus Questionnaire: English (ASQE)
Time frame: At the preparation session, two weeks after the first experimental drug administration session, and two and eight weeks after the second experimental drug administration session
Sheehan Disability Scale (SDS)
Time frame: At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session.
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 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Recruiting
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
Amblyopia
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.
Frederick Barrett, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amblyopia Therapy, 1 mg Psilocybin and 5 mg Psilocybin in people with Amblyopia, run by Johns Hopkins University 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 13 inclusion and 10 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 5 Nov 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Brian Winston (410-550-2253, bwinsto2@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amblyopic Eye Visual Acuity (time frame: from Baseline to two weeks after experimental drug session 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 5 Nov 2026.