A study to understand the effects of a medication prucalopride on mental activities involving thinking, learning,reasoning, and understanding in patients with schizophrenia

Phase 2

• Conditions: Health Condition 1: F20- Schizophrenia

• Registration Number: CTRI/2023/12/060438
• Lead Sponsor: St Johns National Academy Of Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i)Diagnosed as schizophrenia by DSM 5 criteria

ii)Age between 18 to 55 years

iii)A minimum of one year of duration of illness

iv)Clinically stable with a stable therapeutic dose of antipsychotics for at least 3 months prior to the recruitment

v)Participants who can read and write English or Kannada

Exclusion Criteria

i)Participants who are acutely symptomatic and are uncooperative for assessments

ii)Co morbid with other psychiatric illness including mood disorders and substance use disorders except tobacco

iii)Participants already diagnosed with Intellectual Disability Disorder, head injury

iv)Participants administered MECT (modified electroconvulsive therapy) in the past 6 months

v)Participants with uncorrected sensory impairments

vi)Use of Donepezil, Rivastigmine, Memantine, Benzodiazepines

vii)Participants already on prucalopride

viii)Participants with contraindications to prucalopride like hypersensitivity or diagnosed with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, gastrointestinal disorders like Ulcerative colitis, Crohn’s disease, Intestinal ulcers, toxic megacolon or megarectum

ix)Use of concomitant herbal remedies, alternative medicines

x)Women who are pregnant or lactating

xi)Current history of suicidal ideation, intention or attempts as assessed during the clinical interview

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cognitive functioning at the end of 4 weeks and 8 weeks.Timepoint: Assessments will be done at baseline, at the end of 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
2.Change in Scale for the assessment of Positive symptoms (SAPS) and Scale for the assessment of negative symptoms (SANS) scores at the end of 4 weeks and 8 weeks.Timepoint: Assessment will be done at baseline, at the end of 4 weeks and 8 weeks