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Pitolisant Effects on Affect and Cognition Exploratory Study (PEACE Study)

NCT05849675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-14

No results posted yet for this study

Summary

The goal of this study is to investigate the effects of selective histamine 3 antagonist pitolisant on brain function and cognition in healthy individuals. The main questions it aims to answer are:

1. Does pitolisant alter functional activity in brain regions linked to reward and cognitive processing during rest or cognitive task performance?
2. Does pitolisant alter cognitive ability across a range of psychological domains, including working memory, executive functioning and emotional processing?

Participants will undertake fMRI scanning in addition to a battery of tasks designed to measure cognitive and emotional processing after taking a single dose of pitolisant or placebo. Researchers will compare differences in functional activity, cognition and emotional processing across the pitolisant and placebo groups.

Conditions

  • Anhedonia
  • Cognitive Function

Interventions

DRUG

Pitolisant 17.8 MG [Wakix]

Single dose pitoliosant (36mg)

DRUG

Placebo

Single dose placebo

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Susannah E Murphy, DPhil · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-02-18
Completion
2024-05-08

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849675 on ClinicalTrials.gov