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Comparing the efficacy of pimavanserin vs aripiprazole for reducing the psychotic symptoms in dementia

Comparing the efficacy of pimavanserin vs aripiprazole for reducing the psychotic symptoms in dementia-A randomised clinical trial-An open label prospective study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090347
Enrollment
70
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: - Health Condition 2: F039- Unspecified dementia

Interventions

Intervention1: Pimavanserin vs Aripiprazole: Administration of Pimavanserin 34 mg once daily per oral to Group A and Aripiprazole 10-30 mg once daily per oral to Group B for 6 weeks to reduce the psyc

Sponsors

DR KRISHNA MURARI DAKUA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of Dementia Diagnosis of Psychotic symptoms in dementia Newly onset psychotic symptoms after being diagnosed with Dementia Patient s Drug Naive to Atypical Antipsychotics

Exclusion criteria

Exclusion criteria: Unstable and Severe Medical Conditions such as Severe Cardiovascular Diseases End Stage Renal Disease Traumatic Brain Injury Patients on drugs which cause significant QT Prolongation Patients with Neurodevelopmental Disorders such as Intellectual disability History of Schizophrenia Alcohol and Cannabis induced Psychosis or other Primary Psychotic Disorders

Design outcomes

Primary

MeasureTime frame
To compare the response and remission rates between pimavanserin and aripiprazole for psychosis in dementia by assessment of BPRS.Timepoint: Baseline,Week 2, Week 6

Secondary

MeasureTime frame
To compare the safety profiles between pimavanserin and aripiprazole in patients with dementia psychosis. Timepoint: Baseline,Week 2, Week 6

Countries

India

Contacts

Public ContactDR KRISHNA MURARI DAKUA

SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,BLDE UNIVERSITY

spchaukimath@yahoo.com9448139376

Outcome results

None listed

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