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A clinical trial to study the effect of drug on IQ and behavioral problem in Children with Fragile X Syndrome

A Randomized, Double-Blind, Placebo-Controlled Study of Donepezil on Cognitive Function and Behaviour in Children with Fragile X Syndrome

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000229
Enrollment
Unknown
Registered
2009-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: F79- Unspecified intellectual disabilities

Interventions

Intervention1: Donepezil: 2.5mg od for the first 4 weeks than 5 mg od for the next 8 weeks Control Intervention1: Placebo: 2.5mg od for the first 4 weeks than 5 mg od for the next 8 weeks

Sponsors

Dr Jitendra Kumar Sahu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Confirmed genetic diagnosis of fragile X syndrome by PCR & Southern blot; 2. Age 6-15 yrs; 3.Regardless of their IQ level if they were able to complete the required neuropsychological testing

Exclusion criteria

Exclusion criteria: 1.Children below 6 years and beyond 15 years of age; 2. Currently taking any anticholinergic medications or known hypersensitivity to anticholinergic drugs;3.Seizure disorder requiring the use of anticonvulsant medications;4.Clinically significant uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic or hematologic conditions

Design outcomes

Primary

MeasureTime frame
Intelligence Quotient by Kulshreshta adaptation of the Stanford - Binet TestTimepoint: Baseline & 12 week—

Secondary

MeasureTime frame
Childhood Autism Rating ScaleTimepoint: Baseline, 12 Week—

Countries

India

Contacts

Public ContactDr Jitendra Kumar Sahu
jsh2003@gmail.com09810648079

Outcome results

None listed

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