Prucalopride for Cognitive Functioning in Schizophrenia

Sponsor
University of Pittsburgh
Study ID
NCT06474286
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 25, 2024
Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

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 ]

Central Contacts

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