Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474286
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Prucalopride for Cognitive Functioning in Schizophrenia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Pilot Study to Assess the Effect of Prucalopride on Cognitive Functioning in Patients With Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 KS 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
Participants who are diagnosed with schizophrenia attending consultation at the outpatient department OPD of Psychiatry at KS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |