Prucalopride for Cognitive Functioning in Schizophrenia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Positive and Negative Syndrome Scale for Schizophrenia (PANSS )Score — 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) — 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) — 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) — 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) — 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) — 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.

Trial sites (1)

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