Prucalopride for Cognitive Functioning in Schizophrenia

A Pilot Study to Assess the Effect of Prucalopride on Cognitive Functioning in Patients With Schizophrenia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Prucalopride 1 MG

Detailed Description

Prucalopride acts as a high affinity, high selective 5-hydroxy tryptamine receptor agonist. It is a gastrointestinal prokinetic drug predominantly used for constipation. In this study, the effect of prucalopride on cognitive functioning in schizophrenia is studied.

Participants who are diagnosed with schizophrenia, attending consultation at the outpatient department (OPD) of Psychiatry at K.S. Hegde Hospital and Nitte Rural Medical and Psychiatry Centre will be invited to participate in the study through their treating consultant. Interested participants and their Legally acceptable representative (LAR) will be administered the written informed consent. The participant will be screened and on fulfilling the inclusion and exclusion criteria will be enrolled into the study.

Socio demographic details will obtained from the participants. Baseline laboratory analysis which includes complete blood count, random blood sugar, liver function test, renal function test, urine analysis, ECG will be done for all the participants to screen for fitness. Urine pregnancy test will be done for women participants in the reproductive age group.

Positive and Negative Syndrome Scale (PANSS) will be administered to the participants.

Brief assessment of Cognition in Schizophrenia (BACS) will be administered in the following order i. List learning ii. Digit sequencing task iii. Token motor task iv. Verbal fluency: Category Instances, Controlled Oral Word Association Test v. Tower test vi. Symbol coding 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. 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.

At the end of 4 weeks, the participants will be scheduled for the assessments. Laboratory analysis, PANSS and BACS will be administered. Any side effects to the drug will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vishwajit L Nimgaonkar, MD, PhD; Phone Number: 4127265164; Email: vishwajitnl@upmc.edu
• Study Contact Backup: Name: Triptish Bhatia, PhD; Phone Number: +919910107210; Email: trb16@pitt.edu

Study Locations

• India
  • Karnataka
    • Mangalore, Karnataka, India, 575018
      • K S Hegde Medical Academy,
      • Contact: Associate Professor; Phone Number: +918618261610; Email: drsmitha9@gmail.com
      • Contact: Professor and Head; Phone Number: +919818670768; Email: anilpsychiatry@yahoo.co.in
      • Sub-Investigator: Shrinivasa U Bhat, MD
      • Principal Investigator: Smitha Tarachandra, MD
      • Sub-Investigator: Anil Kakunje, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tab. Prucalopride; 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; 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.; Other Names: 5HT4 receptor agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 (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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Fogarty International Center of the National Institute of Health; K S Hegde Medical Academy
• Investigators: Principal Investigator: Vishwajit L Nimgaonkar, MD, PhD, University of Pittburgh

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; cognitive deficits; Prucalopride; neurocognitive impairment
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders; Schizophrenia; Cognition Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Serotonin Receptor Agonists; Pharmacologic Actions; Chemical Actions and Uses; prucalopride; Serotonin 5-HT4 Receptor Agonists
• Other Study ID Numbers: STUDY23010044; D43TW009114 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: One year after publication of this study.
• IPD Sharing Access Criteria: For individual participant data, meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No