ADHD. A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together
Conditions
Interventions
Intervention 1: Intervention Group:
In this group 15 subjects with ADHD were treated with Stimdate® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reac
Treatment - Drugs
Intervention Group:
In this group 15 subjects with ADHD were treated with Stimdate® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 2
The control group contained 15 subjects who were treated with Ritalin® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age 6-16 years old; Presence of mixed AD/HD according to Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV), No psychological medication in 2 weeks prior to the study; signing informed written consent of parents to participate in the study; the ability to comply study visits schedule. Exclusion criteria: Presence of clinically significant gastrointestinal problems, cardiovascular disease, glaucoma, seizure disorder, psychotic disorder, clinical depression, or Tourette's syndrome; Co-morbid conditions including oppositional defiant disorder or conduct disorder, pervasive developmental disorder, depression, or learning disorders
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Profile of illness reported by parents. Timepoint: 4th and 6th week. Method of measurement: The Standard Persian version of Conner’s parent rating scale-revised (CRS-R) was used for the assessment of ADHD in children and adolescents.;Efficacy of treatment. Timepoint: 4th and 6th week. Method of measurement: The Clinical Global Impressions (CGI) Scale used to rate the symptoms change over time, and efficacy of medication, taking into account the patient’s clinical condition by clinicians.;Illness severity. Timepoint: 4th and 6th week. Method of measurement: The Children’s Global Assessment Scale (CGAS) is used to measure the overall severity of disturbance in children. The CGI and CGAS showed acceptable reliability and validity scores in different studies.;Symptoms severity reported by parents. Timepoint: 0,4,6 weeks. Method of measurement: The Child Symptom Inventory-4 (CSI-4) (ADHD part): is also used to measure Symptom Severity scores by teachers and parents24-25. The internal consistency reliability for CSI-4 in literature reported to be 0.74-0.94 and have acceptable criterion validity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug side effects. Timepoint: 4th and 6th week. Method of measurement: checklist by clinical interview and exam. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Shirazi
Mental Health Research Center
Outcome results
None listed