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Prucalopride for Cognitive Functioning in Schizophrenia

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Dec 31, 2026 → May 31, 2028
See other at-risk trials from University of Pittsburgh

Record History

  1. Primary completion pushed from Dec 31, 2026 to May 31, 2028 Start date: Jul 31, 2026 to May 31, 2027 · Completion pushed from Dec 31, 2026 to Dec 31, 2028 · Eligibility criteria expanded, about 17 words Show 3 more changesShow less
    • Start date: Jul 31, 2026 to May 31, 2027
    • Completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 17 words
  2. Start date: Dec 31, 2025 to Jul 31, 2026 Primary completion date: Aug 31, 2026 to Dec 31, 2026v7 Show 1 more changeShow less
    • Primary completion date: Aug 31, 2026 to Dec 31, 2026
  3. Start date: Jun 15, 2025 to Dec 31, 2025 Primary completion date: Mar 31, 2026 to Aug 31, 2026 · Completion date: Aug 31, 2026 to Dec 31, 2026v6 Show 2 more changesShow less
    • Primary completion date: Mar 31, 2026 to Aug 31, 2026
    • Completion date: Aug 31, 2026 to Dec 31, 2026
  4. Start date: Feb 15, 2025 to Jun 15, 2025 Primary completion date: Dec 31, 2025 to Mar 31, 2026 · Completion date: Feb 28, 2026 to Aug 31, 2026v5 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2025 to Mar 31, 2026
    • Completion date: Feb 28, 2026 to Aug 31, 2026
  5. Start date: Nov 15, 2024 to Feb 15, 2025 Primary completion date: Oct 30, 2025 to Dec 31, 2025 · Completion date: Dec 30, 2025 to Feb 28, 2026v4 Show 2 more changesShow less
    • Primary completion date: Oct 30, 2025 to Dec 31, 2025
    • Completion date: Dec 30, 2025 to Feb 28, 2026
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  1. Start date: Aug 15, 2024 to Nov 15, 2024 Primary completion date: Jun 30, 2025 to Oct 30, 2025 · Completion date: Sep 30, 2025 to Dec 30, 2025v3 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2025 to Oct 30, 2025
    • Completion date: Sep 30, 2025 to Dec 30, 2025
  2. Start date: Jul 1, 2024 to Aug 15, 2024 Primary endpoints revised (6)v2 Show 1 more changeShow less
    • Primary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06474286
Lead Sponsor University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health, K S Hegde Medical Academy
Conditions Schizophrenia
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov