Prucalopride for Cognitive Functioning in Schizophrenia

NCT06474286 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY23010044D43TW009114
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A core component of schizophrenia is neurocognitive impairment. The cognitive deficits are prominently seen in memory, attention, working memory, problem solving, processing speed and social cognition. Atypical antipsychotics continue to be the mainstay of treatment in schizophrenia. Promising areas for future research include search for new compounds for cognition enhancement. Prucalopride, a highly selective 5HT4 receptor agonist is a potential drug and its effect on cognition in patients with schizophrenia needs to be studied. An open label, pilot study involving 34 patients with schizophrenia diagnosed as per DSM 5 criteria. The participants will receive Tab. Prucalopride one milligram (1 mg) for a duration of four weeks along with their existing treatment regimen with antipsychotics. Assessments includes PANSS and BACS at baseline and at the end of 4 weeks. The effect of prucalopride on cognitive functioning in patients with schizophrenia is studied.

Conditions

Schizophrenia

Keywords

Schizophrenia; neurocognitive impairment; cognitive deficits; Prucalopride

Outcome Measures

Primary Outcomes (6)

• Positive and Negative Syndrome Scale for Schizophrenia (PANSS )Score

  There will be change is PANSS score at the end of the study. The score is to assess symptoms. Lowest score is 30 and highest is 210.

  PANSS scores measured at baseline and at the end of 4 weeks

• Cognitive Functioning (List learning)

  To study the change in the cognitive functioning as measured by list learning after intervention. Scores range between 0 and 30.

  Baseline and and at the end of 4 weeks

• Cognitive Functioning (Digit sequencing task)

  To study the change in the cognitive functioning as measured by Digit sequencing task after intervention, It ranges from 0 to 28 points

  Baseline and and at the end of 4 weeks

• Cognitive Functioning (Token motor task)

  To study the change in the cognitive functioning as measured by Token motor task after intervention. It ranges from 0 to 100 points,

  Baseline and and at the end of 4 weeks

• Cognitive Functioning (Tower test)

  To study the change in the cognitive functioning as measured by Tower test after intervention

  Baseline and and at the end of 4 weeks

• Cognitive Functioning (Symbol coding)

  To study the change in the cognitive functioning as measured by Symbol coding after intervention. It ranges from 0 to 22 points.

  Baseline and and at the end of 4 weeks

Study Arms (1)

Tab. Prucalopride

EXPERIMENTAL

The study drug Tab. Prucalopride 1 mg (30 tablets) will be dispensed to the participant. They will be explained to take one tablet of 1 mg Prucalopride per oral in the morning.

Drug: Prucalopride 1 MG

Interventions

Prucalopride 1 MG DRUG

The study drug Tab. Prucalopride 1 mg (30 tablets) will be dispensed to the participant. The drug will be procured at the local site manufactured in India only.They will be explained to take one tablet of 1 mg Prucalopride per oral in the morning. The participants will continue their antipsychotic regimen as per orders of their consultant and will continue to purchase their psychiatric medications as earlier. At the end of week 1, participants will be assessed for side effects via telephonic conversation.

Also known as: 5HT4 receptor agonist

Tab. Prucalopride

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed as schizophrenia by DSM 5 criteria using Structured Clinical Interview for DSM disorders
• Age between 18 to 55 years
• A minimum of one year of duration of illness
• Clinically stable with a stable therapeutic dose for at least 3 months prior to the recruitment
• Participants who can read and write English or Kannada

You may not qualify if:

• Participants who are acutely symptomatic and are uncooperative for assessments
• Co morbid with other psychiatric illness including mood disorders and substance use disorders except tobacco
• Participants already diagnosed with Intellectual Disability Disorder, head injury
• Participants administered MECT (modified electroconvulsive therapy)
• Participants with sensory impairments
• Use of Donepezil, Rivastigmine, Memantine, Benzodiazepines
• Participants already on prucalopride
• Participants with contraindications to prucalopride
• Diagnosed with gastrointestinal disorders like Ulcerative colitis, Crohn's disease, Intestinal ulcers
• Use of concomitant herbal remedies, alternative medicines
• Women who are pregnant or lactating
• Current history of suicidal ideation, intention or attempts

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• K S Hegde Medical Academy: collaborator

Study Sites (1)

K S Hegde Medical Academy,

Mangalore, Karnataka, 575018, India

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

prucalopride; Serotonin 5-HT4 Receptor Agonists

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Bhatia, PhD

CONTACT

+919910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An open label, pilot study, interventional study

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)