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Imaging 5HT7 Antagonist Effects in Bipolar Disorder

NCT03633357 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-09-08

No results posted yet for this study

Summary

The main aim of this research is to examine the potential of 5HT7 antagonists for the treatment of cognitive impairment in bipolar disorder by determining the effect of the 5HT7 antagonist JNJ-18038683 on cognitive and emotional processing related brain activity in cognitively impaired people with bipolar disorder and healthy participants using functional MRI (fMRI). This study is designed to contribute to the rational validation of 5HT7 antagonists as a treatment for cognitive impairment in bipolar disorder and to support the development of clinical trials and further drug development in this area. The study will also examine the effect of 5HT7 antagonism on brain function in healthy participants as this has never been investigated before, and to use as a comparator to determine whether 5HT7 antagonism effects disease specific impairments in task related brain activity and cerebral blood flow.

Conditions

Interventions

DRUG

JNJ-18038683

JNJ-18038683 has been developed by Janssen Pharmaceuticals (Johnson and Johnson), and is a relatively selective high affinity functional 5-HT7 receptor antagonist. Participants will take two 10-mg tablets daily, for seven days.

DRUG

Placebo

Participants will take two placebo tablets daily, for seven days.

Sponsors & Collaborators

Principal Investigators

  • Paul Stokes, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03633357 on ClinicalTrials.gov