| CTRI Number |
CTRI/2011/08/001981 [Registered on: 30/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
19/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of methylphenidate and atomoxetine in children with attention deficit hyperactivity disorder |
|
Scientific Title of Study
|
To compare the efficacy and tolerability of methylphenidate and atomoxetine in children with attention deficit hyperactivity disorder.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmin Kaur |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
|
| Address |
Department of Psychiatry,
5th level, D-Block,
Government Medical College and Hospital,
Sector 32, Chandigarh,
India.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
jasmin.arneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Arun |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Psychiatry,
5th level, D-Block,
Government Medical College and Hospital,
Sector 32, Chandigarh,
India.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
911722665253 |
| Fax |
|
| Email |
drpritiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti Arun |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Psychiatry,
5th level, D-Block,
Government Medical College and Hospital,
Sector 32, Chandigarh,
India.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
911722665253 |
| Fax |
|
| Email |
drpritiarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
Department of Psychiatry, 5th level, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jasmin Kaur |
Psychiatry OPD |
Psychiatry OPD,
4th level, B-Block,
Government Medical College and Hospital, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH |
9467526683
jasmin.arneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Medical College and Hospital, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Attention Deficit Hyperactivity Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atomoxetine |
Upto 1.2mg/kg/day for 8 weeks |
| Intervention |
Methylphenidate |
Upto 1mg/kg/day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Mean Clinical Global Impression Severity Scale Score |
8 weeks |
| Mean Social Adjustment Inventory for Children and Adolescent Score |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/10/2010 |
| Date of Study Completion (India) |
31/05/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Garg J, Arun P, Chavan BS. Comparative short-term efficacy and tolerability of methylphenidate and atomoxetine in attention deficit hyperactivity disorder. Indian Pediatr 2014;51:550-4.
2. Garg J, Arun P, Chavan BS. Comparative efficacy of methylphenidate and atomoxetine in oppositional defiant disorder comorbid with attention deficit hyperactivity disorder. Int J Appl Basic Med Res 2015;5:114-8. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|