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Search / Trial NCT07022366

Investigating the Neuropsychological Effects of 5-HT2a Antagonism

Launched by UNIVERSITY OF OXFORD · Jun 6, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Serotonin 2a Pimavanserin

ClinConnect Summary

This clinical trial is investigating how a medication called pimavanserin affects certain brain functions, like memory and decision-making, by targeting a specific serotonin receptor. Serotonin is a chemical that helps regulate mood and behavior, and this study aims to learn more about how blocking this receptor could lead to new treatments for depression. Participants in this trial will be compared to a group receiving a placebo, which is a treatment that contains no active ingredients.

To participate, you need to be between 18 and 45 years old, in good health, and able to understand English. You should not be currently receiving treatment for any mental health conditions or have a history of serious psychiatric disorders. If you join, you'll be asked to avoid alcohol the day before your visit, and you can expect to undergo some cognitive tests to see how pimavanserin affects your brain functions. This study is a valuable step toward understanding how to improve treatments for conditions like depression in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Willing and able to give informed consent for participation in the research
  • Aged 18-45 years
  • Good vision and hearing
  • Body mass index (BMI) within the range of 18-35kg/m2 (This is to ensure an appropriate pharmacokinetic profile for pimavanserin is achieved by all participants)
  • Sufficiently fluent in English to understand tasks
  • Willing to avoid drinking any alcohol the day before the research visit
  • Exclusion Criteria:
  • Currently receiving or seeking treatment for any mental health condition
  • Any past or current history of severe and/or serious psychiatric disorder, including but not limited to schizophrenia, psychosis, bipolar affective disorder, severe major depressive disorder, obsessive compulsive disorder (covered in SCID-5 assessment in screening procedures)
  • ADHD requiring treatment with stimulant or other centrally-acting drugs
  • Regular alcohol consumption of more than 21 units per week
  • A head injury causing concussion or unconsciousness in the past 6 months
  • Pregnancy / intention to become pregnant during the study or breastfeeding
  • Any use of recreational drugs in the last three months
  • Participation in any other drug study in the last three months
  • Participation in any other study with the same tasks in the last year
  • History of cardiac disease or cardiac arrhythmias
  • Prolonged QTc interval on baseline ECG
  • Current usage of other drugs known to prolong QT interval including Class 1A or 3 antiarrhythmics, e.g. certain antibiotics (getifloxacin, moxifloxacin)
  • Current use of drugs that inhibit CYP3A4 (eg Clarithromycin. Diltiazem. Erythromycin. Fluconazole). Participants will be asked to avoid grapefruit juice in the week before the study.
  • Current use of psychoactive medication that in the opinion of the Chief Investigator may interfere with the study measures
  • History of, or current medical condition(s) which, in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, severe hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, severe neurological problems (e.g. Parkinson's disease; blackouts requiring hospitalisation);
  • Any physical (including visual and auditory), cognitive or language impairment that would make complying with the study protocol challenging
  • Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day;
  • Smoking \>10 cigarettes per day; or equivalent nicotine consumption
  • Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the chief investigator.
  • Inability to ingest up to 95mg of lactose
  • Additional Exclusion Criteria for Participants in the Sleep Study Cohort:
  • Unable to undergo cardiac monitoring
  • Unable to wear the sleep patch device for full monitoring period
  • Implanted neurostimulator

About University Of Oxford

The University of Oxford, a prestigious institution renowned for its excellence in research and education, serves as a leading clinical trial sponsor dedicated to advancing medical science and improving patient care. With a rich history of innovation and a multidisciplinary approach, the university leverages its extensive expertise in various fields, including medicine, public health, and biomedical research, to conduct rigorous clinical trials. Collaborating with healthcare professionals, industry partners, and regulatory bodies, the University of Oxford aims to translate groundbreaking research findings into effective therapies and interventions, contributing to the global effort of enhancing health outcomes.

Locations

Oxford, , United Kingdom

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported