HealthyPhase 1MESA-ENCT03934710
Mood Effects of Serotonin Agonists Extended
A Phase 1 study testing Serotonin agonist - 13ug and Serotonin agonist - 26ug in people with Healthy, run by University of Chicago at 1 site in United States.
Trial summary
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Serotonin agonist - 13ug and Serotonin agonist - 26ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2019to 7 Jun 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English fluency
- High school level education
- BMI between 19 and 30
Who cannot join
- Diagnosed medical condition
- women who are nursing, pregnant, or plan to become pregnant within 3 months
- History of psychotic disorder or family history of psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.
Read the detailed description
Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks
- Conditions
- Healthy
- Being tested
- Placebo, Serotonin agonist - 13ug, Serotonin agonist - 26ug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Drug will be administered in solution form
Serotonin agonist - 13ugDrug
Also called LSD
13ug lysergic acid diethylamide
Serotonin agonist - 26ugDrug
Also called LSD
26ug lysergic acid diethylamide
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Serotonin agonist 13ug | Experimental | 13ug of serotonin agonist Receives: Drug: Serotonin agonist - 13ug |
| Serotonin agonist 26ug | Experimental | 26ug of serotonin agonist Receives: Drug: Serotonin agonist - 26ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASS-21
The primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression.
Measured: End of session 5, approximately 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start20 Apr 2019
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934710
- Sponsor's protocol ID
- IRB18-1183
- Other IDs
- 5R01DA002812
- Acronym
- MESA-E
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2019
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Effects of Serotonin Agonists Extended
- ClinicalTrials.gov ID
- NCT03934710
- Acronym / sponsor ID
- MESA-E / IRB18-1183
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.
Detailed description
Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Serotonin agonist 13ug | Experimental | Drug: Serotonin agonist - 13ug13ug of serotonin agonist |
| Serotonin agonist 26ug | Experimental | Drug: Serotonin agonist - 26ug26ug of serotonin agonist |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English fluency
- High school level education
- BMI between 19 and 30
Key exclusion criteria (3 listed)
- Diagnosed medical condition
- women who are nursing, pregnant, or plan to become pregnant within 3 months
- History of psychotic disorder or family history of psychotic disorder
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 |
|---|---|---|
| PlaceboDrug will be administered in solution form | Drug | Placebo |
| Serotonin agonist - 13ugAlso: LSD13ug lysergic acid diethylamide | Drug | Serotonin agonist 13ug |
| Serotonin agonist - 26ugAlso: LSD26ug lysergic acid diethylamide | Drug | Serotonin agonist 26ug |
Primary outcome
DASS-21
Time frame: End of session 5, approximately 2 weeks from baseline
The primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Harriet de Wit principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Serotonin agonist - 13ug and Serotonin agonist - 26ug in people with Healthy, run by University of Chicago 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
DASS-21 (time frame: End of session 5, approximately 2 weeks from baseline). 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 29 Nov 2023.