Skip to content

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

A Pilot Study to Assess the Effect of Prucalopride on Cognitive Functioning in Patients with Schizophrenia - PruCog

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060438
Enrollment
42
Registered
2023-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Tablet Prucalopride 1 milligram: Tablet Prucalopride 1 miligram per oral once in the morning for a duration of 4 weeks. Control Intervention1: not applicable: Open label study hence no

Sponsors

St Johns National Academy Of Health Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactSmitha Tarachandra

K S Hegde Medical Academy

drsmitha9@nitte.edu.in8618261610

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026