Post Traumatic Stress DisorderEarly Phase 1NCT04404712
FAAH Availability in Psychiatric Disorders: A PET Study
A Early Phase 1 study testing [11C]MK-3168 in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by Yale University at 1 site in United States.
Trial summary
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Alcohol Use Disorder, Psychosis
- What is being tested?
- [11C]MK-3168
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 30 Jun 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65 years, inclusive
- Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs
- PTSD Inclusion Criteria:
- Diagnosis of Post-Traumatic Stress Disorder
- AUD Inclusion Criteria:
- Diagnosis of Alcohol Use Disorder
- Psychosis Inclusion Criteria:
- Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder
Who cannot join
- Presence of ferromagnetic metal in the body or heart pacemaker
- Women with a positive pregnancy test or women who are lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.
Read the detailed description
This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals.
- Being tested
- [11C]MK-3168
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]MK-3168Drug
One PET scan involving administration of PET ligand [11C]MK-3168
| Study group | Role | What they receive |
|---|---|---|
| [11C]MK-3168 PET Scan | Experimental | Not described Receives: Drug: [11C]MK-3168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total distribution of [11C]MK-3168 in the brain
FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
Measured: PET scan day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start23 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Ligand was not effective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Yale 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, MBBS, Principal investigator, Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404712
- Sponsor's protocol ID
- 2000027585
- Status last verified
- Feb 2023
- First submitted
- 22 May 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAAH Availability in Psychiatric Disorders: A PET Study
- ClinicalTrials.gov ID
- NCT04404712
- Acronym / sponsor ID
- 2000027585
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ligand was not effective.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 May 2020 (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 aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.
Detailed description
This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C]MK-3168 PET Scan | Experimental | Drug: [11C]MK-3168 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 18 and 65 years, inclusive
- Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs
- Diagnosis of Post-Traumatic Stress Disorder
- Diagnosis of Alcohol Use Disorder
- Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder
Key exclusion criteria (2 listed)
- Presence of ferromagnetic metal in the body or heart pacemaker
- Women with a positive pregnancy test or women who are lactating
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 |
|---|---|---|
| [11C]MK-3168One PET scan involving administration of PET ligand [11C]MK-3168 | Drug | [11C]MK-3168 PET Scan |
Primary outcome
Total distribution of [11C]MK-3168 in the brain
Time frame: PET scan day
FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
Results and safety
The study was stopped early (reason given: Ligand was not effective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Related trials for Post Traumatic Stress Disorder
Not yet recruiting
FUS Neuromodulation for PTSD
Post Traumatic Stress Disorder PTSD
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
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.
Mohini Ranganathan, MBBS principal investigator
Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University
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 [11C]MK-3168 in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by Yale 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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 Feb 2023. 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 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 stopped early (reason given: Ligand was not effective.). Results are not available in the source record.
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?
Total distribution of [11C]MK-3168 in the brain (time frame: PET scan day). 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 Feb 2023.