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

Phase 4
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Registration Number
CTRI/2011/08/001981
Lead Sponsor
Department of Psychiatry
Brief Summary

This study is a prospective, randomized, open label trial comparing efficacy and tolerability of Methylphenidate (upto 1mg/kg/day) and Atomoxetine (upto 1.2mg/kg/day) for 8 weeks in 60 patients with attention deficit hyperactivity disorder which is being conducted in Government Medical College and Hospital, Chandigarh. The primary outcome measures are mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, mean Adverse Effects Checklist Score assessed weekly for 8 weeks and mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score assessed at baseline and 8 weeks. The secondary outcome measures are mean Social Adjustment Inventory for Children and Adolescent score and mean Clinical Global Impression Severity Score at 8 weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
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
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, Mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score, Mean Adverse Effect Checklist Score.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 Outcome Measures
NameTimeMethod
Mean Clinical Global Impression Severity Scale Score8 weeks
Mean Social Adjustment Inventory for Children and Adolescent Score8 weeks

Trial Locations

Locations (1)

Psychiatry OPD

🇮🇳

Chandigarh, CHANDIGARH, India

Psychiatry OPD
🇮🇳Chandigarh, CHANDIGARH, India
Jasmin Kaur
Principal investigator
9467526683
jasmin.arneja@gmail.com

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