Back to search results

Psilocybin and Pimavanserin for Mood and Well-being

This study is looking at how psilocybin, a psychedelic compound, affects mood and well-being in healthy adults. Researchers want to understand if taking pimavanserin (a drug used for certain mental health conditions) or a placebo (an inactive substance) before psilocybin changes its effects. You would receive a single dose of psilocybin (25 mg) along with either pimavanserin (34 mg) or a placebo. The study aims to enroll 20 healthy adults between 21 and 65 years old who are right-handed and fluent in English. Researchers will measure changes in mood and well-being using questionnaires at one week and one month after you receive psilocybin. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 20 healthy adults to evaluate psilocybin with or without pimavanserin pretreatment.
What's involved
You would need to abstain from psychoactive drugs the day before and the day of drug administration, confirmed by a toxicology report. Outcome assessments will occur at 1 week and 1 month after psilocybin administration.
Compensation
Not stated in the trial record.
Follow-up
Your mood and well-being will be assessed at 1 week and 1 month after receiving psilocybin.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07610135

Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Recruiting
PHASE1Ages 21–65InterventionalBasic science
Johns Hopkins University
~20 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:PsilocybinPimavanserinInactive Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Persisting Effects Questionnaire (PEQ) score
Measured over Day 7, Day 30

Conditions

Mood (Psychological Function)
Well Being
Mood
Healthy

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • David B. Yaden, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Arozo Azimi
[email protected]
410-550-0007
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age 21 to 65 years old
Provision of written informed consent
Fluency in English
At least high school level of education
Right-handed
Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report.
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 mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
Agree not to take any PRN medications on the mornings of drug sessions
Agree that for one week before the 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.
Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study.
Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year.
Condoms alone are not considered highly effective.
Abstinence is not considered a highly effective method. However, at the investigator's discretion, abstinence may be accepted if, based on the investigator's judgment and knowledge of the participant's usual and preferred lifestyle, it can be reasonably expected to result in 100% effectiveness.

Exclusion

Non-English speakers and those with language or hearing impairments
Left-handedness (assessed by the Edinburgh Handedness Inventory)
Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)
History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder.
Current use of neuropsychiatric medications, including but not limited to typical/atypical antidepressants, antipsychotics, and stimulants.
Lifetime history of substance use disorder
Current (within past six months) substance use disorder of moderate or greater severity
Clinically significant suicidal ideation (with strong intent or means) within the past 6 months or lifetime history of suicide attempt, current suicidal ideation, or otherwise judged by a study clinician to be more than low risk for suicidality
Current use/positive toxicology for illicit drugs at screening and prior to drug administration session (includes illicit, non-prescribed, or prohibited substances such as amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methadone, opioids, phencyclidine (PCP), and tetrahydrocannabinol (THC))
Nicotine user consuming the equivalent of ≥ 10 cigarettes/day
Altered gastrointestinal anatomy \[history of surgeries that promote a general intestinal malabsorption (e.g., jejunoileal bypass, jejunocolic bypass, roux-en-Y gastric bypass, vertical banded gastroplasty, gastric band, gastric stapling, sleeve gastrectomy, biliopancreatic diversion with partial gastrectomy, distal gastric bypass, duodenal switch)\]
Weight \< 40kg
Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder
MRI contraindications (e.g., claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body). Must complete MRI screening form and be approved by MRI technologist before each scan.
Unable or unwilling to perform study procedures, or inappropriate for further study participation as determined by the PI and/or study clinicians

What this trial measures

  • Persisting Effects Questionnaire (PEQ) scoreDay 7, Day 30

    Persisting effects will be assessed using the single item well-being item from the Persisting Effects Questionnaire (PEQ) at 1-week (primary inferential contrast) and 1-month post-dosing. The PEQ is an instrument designed to measure participants' retrospective attributions regarding the longer-term impact of the psilocybin experience, including effects on mood, behavior, and overall well-being. The item is rated on a 7-point Likert scale (-3 = decreased very much; -2 = decreased moderately; -1 = decreased slightly; 0 = no change; 1 = increased slightly; 2 = increased moderately; 3 = increased very much). Score range -3 to 3.