Prucalopride for Cognitive Functioning in Schizophrenia
ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Pittsburgh
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Prucalopride 1 MG
DrugThe 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.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Tab. PrucaloprideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
K S Hegde Medical Academy
Collaborator
Source ClinicalTrials.gov
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