SchizophreniaNCT06474286
Prucalopride for Cognitive Functioning in Schizophrenia
A study testing Prucalopride 1 MG in people with Schizophrenia, run by University of Pittsburgh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Prucalopride 1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 31 May 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
K S Hegde Medical Academy,
Mangalore, Karnataka, 575018
Associate Professor, +918618261610, drsmitha9@gmail.com
Professor and Head, +919818670768, anilpsychiatry@yahoo.co.in
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Prucalopride 1 MG
- Keywords
- Schizophrenia, neurocognitive impairment, cognitive deficits, Prucalopride
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prucalopride 1 MGDrug
Also called 5HT4 receptor agonist
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Prucalopride 1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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,
Measured: 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
Measured: 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.
Measured: Baseline and and at the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start31 May 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label, pilot study, interventional study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, K S Hegde Medical Academy
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474286
- Sponsor's protocol ID
- STUDY23010044
- Other IDs
- D43TW009114
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effect of Prucalopride on Cognitive Functioning in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06474286
- Acronym / sponsor ID
- STUDY23010044
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, neurocognitive impairment, cognitive deficits, Prucalopride
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, K S Hegde Medical Academy
- Study start
- 31 May 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label, pilot study, interventional study
| Arm | Type | Receives |
|---|---|---|
| Tab. Prucalopride | Experimental | Drug: Prucalopride 1 MGThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prucalopride 1 MGAlso: 5HT4 receptor agonistThe 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. | Drug | Tab. Prucalopride |
Primary outcome
Positive and Negative Syndrome Scale for Schizophrenia (PANSS )Score
Time frame: PANSS scores measured at baseline and at the end of 4 weeks
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.
Cognitive Functioning (List learning)
Time frame: Baseline and and at the end of 4 weeks
To study the change in the cognitive functioning as measured by list learning after intervention. Scores range between 0 and 30.
Cognitive Functioning (Digit sequencing task)
Time frame: Baseline and and at the end of 4 weeks
To study the change in the cognitive functioning as measured by Digit sequencing task after intervention, It ranges from 0 to 28 points
Cognitive Functioning (Token motor task)
Time frame: Baseline and and at the end of 4 weeks
To study the change in the cognitive functioning as measured by Token motor task after intervention. It ranges from 0 to 100 points,
Cognitive Functioning (Tower test)
Time frame: Baseline and and at the end of 4 weeks
To study the change in the cognitive functioning as measured by Tower test after intervention
Cognitive Functioning (Symbol coding)
Time frame: Baseline and and at the end of 4 weeks
To study the change in the cognitive functioning as measured by Symbol coding after intervention. It ranges from 0 to 22 points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prucalopride 1 MG in people with Schizophrenia, run by University of Pittsburgh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishwajit L Nimgaonkar, MD, PhD (4127265164, vishwajitnl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale for Schizophrenia (PANSS )Score (time frame: PANSS scores measured at baseline and at the end of 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.