An interventional study of Prucalopride 1 MG in Schizophrenia, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 34 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: 5HT4 receptor agonist
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.
Time frame: 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.
Time frame: 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
Time frame: 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,
Time frame: 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
Time frame: 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.
Time frame: Baseline and and at the end of 4 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan
Time frame: One year after publication of this study.
Access criteria: For individual participant data, meta-analysis.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prucalopride