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A clinical trial to study the effects of drug, methylphenidate in children having attention-deficit/ hyperactivity disorder with or without intellectual disability

Effectiveness and tolerability of methylphenidate for ADHD in children with intellectual disability as compared with those without intellectual disability

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010722
Enrollment
60
Registered
2017-11-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Attention deficit hyperactivity disorder (with and without intellectual disability)

Interventions

Intervention1: Methylphenidate: Methylphenidate Immediate release preparation shall comprise the treatment for all the participants. Prescribed in one single morning dose (8 am) or two divided doses (
as well as considering the overall severity of side effects.

Sponsors

Postgraduate Institute of Medical Education anmd Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with ADHD (as per DSM IV diagnosis confirmed by MINI- KID) and - 2. Drug naïve or 3. Past treatment with any medication for ADHD, but off medications fo

Exclusion criteria

Exclusion criteria: 1. Any other co-morbid psychiatric illness (other than autism, oppositional defiant disorder or conduct disorder, or problem behaviors) 2. Diagnosed with epilepsy or any cardiac disease 3. Presence of tics/ tic disorder 4. Current use of stimulant or any other medication specifically for ADHD symptoms (e.g. clonidine) or an antipsychotic drug 5. History of sensitivity to use of stimulant medication

Design outcomes

Primary

MeasureTime frame
1. Connersâ?? Parent rating scale (short) 2. Vanderbilt ADHD Diagnostic Parent Rating Scale 3. Aberrant Behaviour Checklist 4. Continuous Performance Task Test 5. Clinical Global Impression scale (Severity and Improvement) 6. Childrens Global Assessment Scale (CGAS) 7. Instrument to measure side effects Timepoint: 1. 2-4 weeks 2. 6-8 weeks 3. 10-12 weeks 4. 16-20 weeks 5. 6-8 months 6. 10-12 months

Countries

India

Contacts

Public ContactRuchita Shah
drruchitashah@gmail.com

Outcome results

None listed

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