Obsessive-Compulsive DisorderPhase 1/2NCT04880278
Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
A Phase 1/2 study testing Nabilone in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Nabilone
- 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
- 1 Mar 2022to 8 May 2024
- Phase
- Phase 1/2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 21-55 years of age
- Physically healthy and, if female, not pregnant
- Able to tolerate all study procedures
- Able to provide written informed consent to participate
- Right-handed
- Primary diagnosis of OCD
- Not taking psychotropic medications or other substances likely to interact with nabilone
Who cannot join
- History of any significant medical condition that may increase the risk of participation
- Females who are pregnant or nursing
- Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
- Current substance use disorder
- Positive urine toxicology or alcohol breathalyzer
- Any history of adverse reaction to a cannabinoid
Show all 9Show fewer
- History of receiving cognitive behavior or exposure-based psychotherapy in the past 3 months
- History of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- History of claustrophobia or unable to tolerate confined spaces like an MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The purpose of this research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. OCD is a disabling illness that affects around 2% of the population and involves recurrent intrusive thoughts (obsessions) and repetitive behaviors (compulsions) that lead to distress and/or impaired functioning. Nabilone is a synthetic form of delta-9-tetrahydrocannabinol (THC, the primary psychoactive component of the cannabis plant). It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD symptoms. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.
In this study, 60 adults with OCD will receive a single dose of either nabilone or placebo. Participants will then complete a series of assessments including neuroimaging, psychophysiology (e.g., skin conductance recording), computerized behavioral tasks, and self-report measures. The information gained from this study could contribute to the development of new treatments for people with OCD and related disorders.
Read the detailed description
The total time required for each participant is 4 visits, as outlined below:
Visit 1: Screening, Questionnaires, and Orientation: During this visit potential participants will learn about the study procedures, sign the informed consent documents, complete diagnostic evaluations and medical screening with study staff. Participants will also complete a series of forms that ask about demographic information, OCD symptoms, use of drugs and alcohol, and other aspects of physical and mental health.
Visit 2: Behavioral Tests: During this visit participants will complete several computer tasks. Study staff will measure reaction time and obtain psychophysiological information (e.g., skin conductance recordings). The tasks that the participant completes will involve viewing images within a virtual environment. An aversive stimulus (e.g., loud burst of noise, animated snake) may follow one image most of the time, while other images may never be followed by a noise or a snake. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown, and will be asked to repeatedly rate on a scale how likely they think it is that a noise/snake will occur after each image.
Visit 3: Behavioral Tests with Drug or Placebo and MRI scan: For safety reasons, participants will be asked not to take any drugs for at least 24 hours before this visit. They will also be asked not to use marijuana/cannabis for at least 2 weeks before participating. Participants will be required to test negative on a urine drug screen and breathalyzer before continuing with this visit; women must also have a negative pregnancy test. Participants will need to complete a field sobriety test at the end of this visit and will be asked not to drive or operate machinery for the following 24 hours; participants not traveling to the clinic by subway or taxi should arrange to have a friend or family member pick them up.
Two hours before beginning the Visit 3 tasks, participants will be asked to swallow a capsule containing either nabilone or placebo (sugar pill). Nabilone is a Food \& Drug Administration (FDA) approved medication, and the dose (1mg, one time) is unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires asking about how they are feeling at the moment. At the end of the session, they will also be asked to guess whether they received nabilone or placebo.
Participants will then complete a task that is similar to the one on the previous day (Visit 2), but will be completed in the MRI scanner. During the MRI scan, participants will view the same images as on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. They will again be asked to rate how much they expect to experience the aversive stimulus after each image and to self-report their level of anxiety on a scale from 0 to 100. Finally, they will be asked to relax with their eyes open while viewing a white fixation cross on a back background.
Participants will complete an additional task outside of the MRI scanner. Participants will be repeatedly asked to view and choose between different images (e.g., spaceships), which lead to a different set of images. They must select one image from this second set, with some choices leading to a small monetary reward.
Visit 4: Behavioral Tests and MRI scan: This visit will be very similar to Visit 3, except that participants will not receive any study medication. Participants will complete the same type of task inside the MRI scanner, while the study staff measures reaction time, psychophysiological response, and brain activation. Participants will view the same images as in Visits 2 and 3, and may experience the same aversive stimulus. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and to report their level of anxiety on a scale from 0 to 100. Participants will again be asked to relax with their eyes open while viewing a white fixation cross on a black background. Finally, outside of the scanner, participants will complete another decision-making task similar to the one they completed the day before.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Nabilone, Placebo
- Keywords
- Nabilone, Fear Extinction, Threat Response, Goal-directed vs. Habitual Behavior, fMRI
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Also called Cesamet (brand name)
Half of the participants (30 individuals) will receive nabilone 1mg. Nabilone will be placed in opaque capsules with dextrose filler and administered by mouth only once (around 120 minutes prior to fMRI scanning).
PlaceboDrug
Half of the participants (30 individuals) will receive placebo capsules that are opaque and contain only dextrose. Placebo capsules will be administered by mouth only once (around 120 minutes prior to fMRI scanning).
| Study group | Role | What they receive |
|---|---|---|
| Nabilone | Active comparator | In a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD. Receives: Drug: Nabilone |
| Placebo | Placebo comparator | In a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Measure 1
Functional magnetic resonance imaging (fMRI) BOLD percent signal change within regions of interest (e.g., amygdala; ventromedial prefrontal cortex; hippocampus) during task performance
Measured: 5 years
Brain Measure 2
Difference in fMRI resting state functional connectivity
Measured: 5 years
Skin conductance response (SCR)
Change in SCR (peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation).
Measured: 5 years
Electromyography (EMG)
Change in orbicularis oculi EMG response (peak-to-peak value in the 21-150ms after stimulus presentation)
Measured: 5 years
Expectancy Ratings
To assess the expected likelihood that an aversive cue (e.g. noise burst or animated snake) will occur or not based on which image was shown, participants will repeatedly rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 (1 = certain that the aversive cue will be presented; 2 = certain that the aversive cue will not be presented; 3 = uncertain whether the aversive cue will be presented).
Measured: 5 years
Secondary outcomes (10)
Two-step task performance
Computational modeling will be applied to examine the balance between model-free vs. model-based behavior based on the relative frequency of outcomes selected at each stage of the task (i.e., Choice 1 vs. Choice 2).
Measured: 5 years
Subjective Units of Distress
Subjective Units of Distress (SUDS): Self-reported fear/anxiety on a scale from 0-100; taken at three time points throughout the tasks: before the task begins, in the middle of the task, and at the end of the task.
Measured: 5 years
Yale-Brown Obsessive-Compulsive Challenge Scale
Measure of self-reported obsessions and compulsions over short timeframes (e.g., minutes to hours).
Measured: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Spielberger State/Trait Anxiety Inventory (STAI)
Self-report measure of trait anxiety and of current anxiety symptoms
Measured: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Visual Analog Scales (VAS)
Measures self-report of current OCD and anxiety symptoms on a visual scale of 1-10
Measured: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Nabilone Side Effects Checklist
Self-report checklist of potential nabilone side effects on a scale of 1-4 (absent, mild, moderate, severe)
Measured: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Drug Effects Questionnaire (DEQ)
Self-report measure of intoxicating effects on a scale of 1-4
Measured: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 90, 120, 150, 180, and 240 minutes afterwards, as well as at 8 hours and 24 hours afterwards.
End of Session Questionnaire (ESQ)
A brief questionnaire that asks participants about their experiences during the experimental session
Measured: 5 years
Heart rate
Heart rate in beats per minute
Measured: Heart rate will be collected at the following intervals during Visit 3: Immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Blood pressure
Blood pressure (systolic blood pressure/diastolic blood pressure; units: mmHg)
Measured: Blood pressure will be collected at the following intervals during Visit 3: Immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Mar 2022
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: The Principal Investigator is no longer at the Institution and a request for early termination of the grant supporting the study was submitted to NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Reilly Kayser, MD, Principal investigator, Columbia University/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880278
- Sponsor's protocol ID
- 7809
- Other IDs
- K23MH125315
- Status last verified
- May 2024
- First submitted
- 29 Apr 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT04880278
- Acronym / sponsor ID
- 7809
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Nabilone, Fear Extinction, Threat Response, Goal-directed vs. Habitual Behavior, fMRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Principal Investigator is no longer at the Institution and a request for early termination of the grant supporting the study was submitted to NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 10 May 2021 (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 research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. OCD is a disabling illness that affects around 2% of the population and involves recurrent intrusive thoughts (obsessions) and repetitive behaviors (compulsions) that lead to distress and/or impaired functioning. Nabilone is a synthetic form of delta-9-tetrahydrocannabinol (THC, the primary psychoactive component of the cannabis plant). It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD symptoms. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.
In this study, 60 adults with OCD will receive a single dose of either nabilone or placebo. Participants will then complete a series of assessments including neuroimaging, psychophysiology (e.g., skin conductance recording), computerized behavioral tasks, and self-report measures. The information gained from this study could contribute to the development of new treatments for people with OCD and related disorders.
Detailed description
The total time required for each participant is 4 visits, as outlined below:
Visit 1: Screening, Questionnaires, and Orientation: During this visit potential participants will learn about the study procedures, sign the informed consent documents, complete diagnostic evaluations and medical screening with study staff. Participants will also complete a series of forms that ask about demographic information, OCD symptoms, use of drugs and alcohol, and other aspects of physical and mental health.
Visit 2: Behavioral Tests: During this visit participants will complete several computer tasks. Study staff will measure reaction time and obtain psychophysiological information (e.g., skin conductance recordings). The tasks that the participant completes will involve viewing images within a virtual environment. An aversive stimulus (e.g., loud burst of noise, animated snake) may follow one image most of the time, while other images may never be followed by a noise or a snake. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown, and will be asked to repeatedly rate on a scale how likely they think it is that a noise/snake will occur after each image.
Visit 3: Behavioral Tests with Drug or Placebo and MRI scan: For safety reasons, participants will be asked not to take any drugs for at least 24 hours before this visit. They will also be asked not to use marijuana/cannabis for at least 2 weeks before participating. Participants will be required to test negative on a urine drug screen and breathalyzer before continuing with this visit; women must also have a negative pregnancy test. Participants will need to complete a field sobriety test at the end of this visit and will be asked not to drive or operate machinery for the following 24 hours; participants not traveling to the clinic by subway or taxi should arrange to have a friend or family member pick them up.
Two hours before beginning the Visit 3 tasks, participants will be asked to swallow a capsule containing either nabilone or placebo (sugar pill). Nabilone is a Food \& Drug Administration (FDA) approved medication, and the dose (1mg, one time) is unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires asking about how they are feeling at the moment. At the end of the session, they will also be asked to guess whether they received nabilone or placebo.
Participants will then complete a task that is similar to the one on the previous day (Visit 2), but will be completed in the MRI scanner. During the MRI scan, participants will view the same images as on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. They will again be asked to rate how much they expect to experience the aversive stimulus after each image and to self-report their level of anxiety on a scale from 0 to 100. Finally, they will be asked to relax with their eyes open while viewing a white fixation cross on a back background.
Participants will complete an additional task outside of the MRI scanner. Participants will be repeatedly asked to view and choose between different images (e.g., spaceships), which lead to a different set of images. They must select one image from this second set, with some choices leading to a small monetary reward.
Visit 4: Behavioral Tests and MRI scan: This visit will be very similar to Visit 3, except that participants will not receive any study medication. Participants will complete the same type of task inside the MRI scanner, while the study staff measures reaction time, psychophysiological response, and brain activation. Participants will view the same images as in Visits 2 and 3, and may experience the same aversive stimulus. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and to report their level of anxiety on a scale from 0 to 100. Participants will again be asked to relax with their eyes open while viewing a white fixation cross on a black background. Finally, outside of the scanner, participants will complete another decision-making task similar to the one they completed the day before.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabilone | Active comparator | Drug: NabiloneIn a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD. |
| Placebo | Placebo comparator | Drug: PlaceboIn a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between 21-55 years of age
- Physically healthy and, if female, not pregnant
- Able to tolerate all study procedures
- Able to provide written informed consent to participate
- Right-handed
Key exclusion criteria (9 listed)
- History of any significant medical condition that may increase the risk of participation
- Females who are pregnant or nursing
- Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
- Current substance use disorder
- Positive urine toxicology or alcohol breathalyzer
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 |
|---|---|---|
| NabiloneAlso: Cesamet (brand name)Half of the participants (30 individuals) will receive nabilone 1mg. Nabilone will be placed in opaque capsules with dextrose filler and administered by mouth only once (around 120 minutes prior to fMRI scanning). | Drug | Nabilone |
| PlaceboHalf of the participants (30 individuals) will receive placebo capsules that are opaque and contain only dextrose. Placebo capsules will be administered by mouth only once (around 120 minutes prior to fMRI scanning). | Drug | Placebo |
Primary outcome
Brain Measure 1
Time frame: 5 years
Functional magnetic resonance imaging (fMRI) BOLD percent signal change within regions of interest (e.g., amygdala; ventromedial prefrontal cortex; hippocampus) during task performance
Brain Measure 2
Time frame: 5 years
Difference in fMRI resting state functional connectivity
Skin conductance response (SCR)
Time frame: 5 years
Change in SCR (peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation).
Electromyography (EMG)
Time frame: 5 years
Change in orbicularis oculi EMG response (peak-to-peak value in the 21-150ms after stimulus presentation)
Expectancy Ratings
Time frame: 5 years
To assess the expected likelihood that an aversive cue (e.g. noise burst or animated snake) will occur or not based on which image was shown, participants will repeatedly rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 (1 = certain that the aversive cue will be presented; 2 = certain that the aversive cue will not be presented; 3 = uncertain whether the aversive cue will be presented).
10 secondary outcomes
Two-step task performance
Time frame: 5 years
Subjective Units of Distress
Time frame: 5 years
Yale-Brown Obsessive-Compulsive Challenge Scale
Time frame: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Spielberger State/Trait Anxiety Inventory (STAI)
Time frame: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Visual Analog Scales (VAS)
Time frame: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Nabilone Side Effects Checklist
Time frame: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Drug Effects Questionnaire (DEQ)
Time frame: Collected on Visit 3, immediately before capsule ingestion (Time 0), and 30, 60, 90, 120, 150, 180, and 240 minutes afterwards, as well as at 8 hours and 24 hours afterwards.
End of Session Questionnaire (ESQ)
Time frame: 5 years
Heart rate
Time frame: Heart rate will be collected at the following intervals during Visit 3: Immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
Blood pressure
Time frame: Blood pressure will be collected at the following intervals during Visit 3: Immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards.
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 21 May 2024.
- Individual participant dataSharing planned: No
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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.
Reilly Kayser, MD principal investigator
Columbia University/New York State Psychiatric Institute
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 Nabilone in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute 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 7 inclusion and 9 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 21 May 2024. 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 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?
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?
Brain Measure 1 (time frame: 5 years). The study lists 5 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 21 May 2024.