Adhd
Conditions
Brief summary
This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment
Detailed description
This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.
Interventions
DRUGprolong-release methylphenidate
This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Ages 6 to 12 years * Diagnosis of ADHD according to DSM-5 of ICD-10 * Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening * Patient who has a stable clinical symptoms. * Patients or their legal representatives provide informed consent prior to enrollment
Exclusion criteria
* Patients who present of a serious obstructive gastrointestinal disease * Patients cannot swallow the whole tablet * Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study * Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder * Patients or patients' family have a history of poor compliance * Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days * Patients who receiving PR-MPH except stop taking more than 7 days * Patients' parent has a family problem and currently treatment with family therapy or adjust medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score | baseline, 4 and 8 week | SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in Clinical Global Impression-Severity (CGI-S) scale | baseline, 4 and 8 week | CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients) |
| The difference in discontinuation rate between two groups of treatment | 4 and 8 week | Discontinuation rate is a proportion of patients who discontinue medication from any reason |
| The difference in adverse events rate between two groups of treatment | baseline, 4 and 8 week | adverse events rate is a proportion of patients who have the adverse events |
Contacts
Primary ContactChanatthida Muangkum
Outcome results
None listed