Prucalopride and Cognition in Recovered Depression

NCT05220228 | Completed

• 1 other identifier: R77135/RE001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The current study has two aims:

1. 1.To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression.
2. 2.To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin.

Conditions

Depression in Remission

Keywords

Cognition; Emotional processing

Outcome Measures

Primary Outcomes (1)

• Performance (accuracy) across cognitive battery

  To investigate the pattern of effects of sub-acute administration of 2mg prucalopride versus placebo on a battery of cognitive measures including attention (DSST), memory (AVLT), executive function (TMT-A/B), working memory (N-back), and reward sensitivity (PILT).

  Day 7-10

Secondary Outcomes (5)

• FERT

  D7-10

• ECAT/EREC/EMEM

  D7-10

• FDOT

  D7-10

• Emotional go/no-go

  D7-10

• PDQ-20

  D7-10

Study Arms (2)

Prucalopride

EXPERIMENTAL

Prucalopride - 1mg for 2 days, and then increased to 2mg for a further 5-8 days. Testing will occur on day 7 ideally, but may take place up to and including day 10.

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Placebo (sucrose / lactose) for 7-10 days

Drug: Placebo

Interventions

Prucalopride DRUG

1mg prucalopride x 2d, 2mg prucalopride x 5-8d

Also known as: Resolor, Montegrity, Axunio

Prucalopride

Placebo DRUG

Lactose / sucrose placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the research
• Male or female
• Body mass index in the range of 18 to 33
• Not currently taking any medications (except for contraception), including being antidepressant free for at least three months
• Have at least two previous episodes of depression, and have been recovered from the most recent episode of depression for six months
• Current PHQ-9 score \< 10 (the cut off for DSM major depression)

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Any current Axis 1 DSM-5 psychiatric disorder
• Any previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD (Obsessive Compulsive Disorder) or PTSD.
• A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia
• Body Mass Index outside the range of 18 to 33 inclusive
• Any significant current medical condition likely to interfere with conduct of the study or analysis of data
• Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks)
• High consumption of licit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine)
• Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study
• Currently pregnant or breast feeding
• Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome
• Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose
• Participation in a study that involves the use of a medication or novel vaccine within the last three months
• Participation in a study using the same tasks in the last two years
• Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Department of Psychiatry, Warneford Hospital, University of Oxford

Oxford, Oxfordshire, United Kingdom

Location

MeSH Terms

Interventions

prucalopride

Study Officials

• Angharad de Cates, MRCPsych

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 2, 2022
• Study Start: January 4, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

GB (1)