Effects of Acute Prucalopride Administration in Healthy V... | NCT03863366

Studies
Effects of Acute Prucalopride Administration in Healthy Volunteers

NCT03863366

Sponsor

University of Oxford

Status

Completed

Last Update Posted

Mar 5, 2019Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Molecular Mechanisms of Pharmacological Action
Depression
Depressive Disorder
Mood Disorders
Mental Disorder
Antidepressive Agents
Cognition

Interventions

Prucalopride
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2017Actual

Primary Completion Date

Aug 8, 2017Actual

Completion Date

Aug 8, 2017Actual

First Submitted Date

Feb 26, 2019

First Submission Date that Met QC Criteria

Mar 1, 2019

First Posted Date

Mar 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2019

Last Update Posted Date

Mar 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive a single dose of either prucalopride (1mg) or placebo. All participants will come for a Screening Visit to ensure their suitability for the study. If they meet study criteria, they will be invited to a Research Visit, where they will receive the study medication and wait for two hours while the drug reaches peak levels. After two hours they will be asked to complete a series of computer-based tasks measuring emotional, non-emotional cognitive processing, and reward processing. The primary study hypothesis is that acute prucalopride administration will have positive effects on processing facial expressions of emotion. Secondary hypotheses are that acute prucalopride administration will affect other measures of emotional processing, and non-emotional cognition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prucalopride	Experimental	1mg prucalopride capsule	Drug: Prucalopride
Placebo	Placebo Comparator	Lactose placebo capsule	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prucalopride	Drug	1mg prucalopride tablet, encapsulated in white capsule	Prucalopride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recognition of positive and negative facial expressions	Accuracy to identify positive vs. negative facial expressions of emotion on the FERT	Day 1: 2-5 hours post drug administration

Secondary Outcomes

Measure	Description	Time Frame
Recall of emotional words	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task	Day 1: 2-5 hours post drug administration
Recognition of emotional words

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female
Aged 18-40 years
Willing and able to give informed consent for participation in the study
Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
Any past or current Axis 1 DSM-IV psychiatric disorder
Significant medical condition
Current or past gastro-intestinal disorder or irritable bowel syndrome
Current pregnancy or breastfeeding
Known lactate deficiency or any other problem absorbing lactose, galactose or glucose
Current or past history of drug or alcohol dependency
Participation in a psychological or medical study involving the use of medication within the last 3 months
Previous participation in a study using the same, or similar, emotional processing tasks
Smoker > 5 cigarettes per day
Typically drinks > 6 caffeinated drinks per day

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susannah E Murphy, DPhil	University of Oxford	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oxford		Oxford		OX3 7JX	United Kingdom

Label	URL
Psychopharmacology and Emotion Research Laboratory	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C406662	prucalopride

Intervention Model Description

Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg of the drug. Participants in the placebo group will receive a lactose placebo. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.