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A clinical trial to compare the effect of methylphenidate and atomoxetine in children with attention deficit hyperactivity disorder

To compare the efficacy and tolerability of methylphenidate and atomoxetine in children with attention deficit hyperactivity disorder.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001981
Enrollment
60
Registered
2011-08-30
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

Interventions

Intervention1: Methylphenidate: Upto 1mg/kg/day for 8 weeks Control Intervention1: Atomoxetine: Upto 1.2mg/kg/day for 8 weeks

Sponsors

Department of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients from 6 to 15 years of age with the diagnosis of Attention Deficit Hyperactivity Disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision. Patients with moderate to severe illness as assessed by Clinical Global Impressions Severity Scale. Patients whose parents are willing to provide informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: Patients with history of non-response or adverse drug reactions to methylphenidate or atomoxetine in the past. Patients who have taken any medication for ADHD in past one month. Patients with history of heart disease, seizures, bipolar affective disorder, psychotic illness, pervasive developmental disorder, substance abuse, anxiety, mental retardation or tic disorder.

Design outcomes

Primary

MeasureTime frame
Mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, Mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score, Mean Adverse Effect Checklist Score.Timepoint: Weekly assessments on Vanderbilt ADHD Diagnostic Parent Rating Scale and Adverse Effect Checklist for 8 weeks. Vanderbilt ADHD Diagnostic Teacher Rating Scale Assessment at baseline and 8 weeks.

Secondary

MeasureTime frame
Mean Clinical Global Impression Severity Scale ScoreTimepoint: 8 weeks;Mean Social Adjustment Inventory for Children and Adolescent ScoreTimepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Priti Arun

Government Medical College and Hospital

drpritiarun@gmail.com911722665253

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 20, 2026