Corresponding author

2009

The aim of this randomized clinical trial was to assess the efficacy of stimdate compared to ritalin in the treatment of children with attention deficit hyperactivity disorder (ADHD). Method: Sixty four subjects (45 boys and 15 girls) aged 5-13 who were diagnosed with ADHD based on (DSM-IV-TR) criteria were selected for this study. The subjects were randomly assigned to two groups: one group with 30 subjects received stimdate and the other group of 30 subjects received ritalin for 6 weeks. Treatment outcomes were assessed using the Attention Deficit Hyperactivity Rating Scale administered at baseline and on weeks 2, 4 and 6 following the treatment. A two-way repeated measures analysis of variance (time-treatment interaction) was used. Results: There were no significant differences between sex, age, weight, and ethnicity of the participants in the 2 groups. Both groups showed a significant improvement during the 6 weeks of the treatment period, and this improvement was due to the parents' ADHD Rating Scale during the treatment. Conclusion: Based on the results of this study, no significant difference was observed between the two medications, and it seems both drugs behave in a similar way. In addition, stimdate appears to be effective and well tolerated for ADHD in children and adolescents in Iran.

Iran J Psychiatry Behav Sci, 2012

Objective: To compare the effectiveness and safety of the methylphenidate produced in Iran (Stimdate®) with its original brand (Ritalin®) in children with Attention deficit hyperactivity disorder (ADHD). Methods: In this double-blinded randomized clinical trial, 30 patients with ADHD who were 6 to 16 years old, were divided into two groups: 15 in Stimdate® and 15 in Ritalin® group. The two groups were compared for side effects profile, Conner's Parent's Rating Scale-Persion version (CPRS-R), Child Symptom Inventory-4 (CSI-4), Clinical Global Impressions (CGI), and Children's Global Assessment Scale (CGAS), at baseline and at the 4 th and 6 th weeks. Results: The subjects showed significant decreases in the CPRS-Rand CSI-4 scores and significant increase of CGAS scores during the follow-up, but there were no significant difference between Stimdate® and Ritalin® group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects were not significantly different between the two studied groups. Conclusions: Both Stimdate® and Ritalin® had comparable clinical efficacy and safety in children with ADHD.

2012

Objective: To compare the effectiveness and safety of the methylphenidate produced in Iran (Stimdate®) with its original brand (Ritalin®) in children with Attention deficit hyperactivity disorder (ADHD). Methods: In this double-blinded randomized clinical trial, 30 patients with ADHD who were 6 to 16 years old, were divided into two groups: 15 in Stimdate® and 15 in Ritalin® group. The two groups were compared for side effects profile, Conner’s Parent’s Rating Scale-Persion version (CPRS-R), Child Symptom Inventory-4 (CSI-4), Clinical Global Impressions (CGI), and Children’s Global Assessment Scale (CGAS), at baseline and at the 4 th and 6 th weeks. Results: The subjects showed significant decreases in the CPRS-Rand CSI-4 scores and significant increase of CGAS scores during the follow-up, but there were no significant difference between Stimdate® and Ritalin® group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects were not signific...

Archives of General Psychiatry

We wanted to study the effects of amphetamine on symptoms of attention-deficit hyperactivity disorder (ADHD) over a longer period than has been reported in previous studies of central stimulants in this condition. Sixty-two children, aged 6 to 11 years, meeting DSM-III-R symptom criteria for ADHD participated in a parallel-group design, randomized, double-blind, placebo-controlled study of amphetamine treatment. Treatment was not restricted to children with "pure" ADHD, ie, some had comorbid diagnoses. In the amphetamine group, children received active treatment for 15 months. Amphetamine was clearly superior to placebo in reducing inattention, hyperactivity, and other disruptive behavior problems and tended to lead to improved results on the Wechsler Intelligence Scale for Children--Revised. Treatment failure rate was considerably lower and time to treatment failure was longer in the amphetamine group. Adverse effects were few and relatively mild. The results of this long...

Journal of the American Academy of Child & Adolescent Psychiatry, 2005

Objective: This study examined the effectiveness of stimulant medication on multiple domains of functioning in 36 young (5 to 6 years old) children diagnosed with attention-deficit/hyperactivity disorder (ADHD). Method: Five-and 6-year-old children attending a summer treatment program between 1987 and 1997 underwent a randomized clinical assessment of the effect of two doses of methylphenidate (0.3 mg/kg versus 0.6 mg/kg) and placebo on social behavior and academic performance. Results: Methylphenidate had an effect on all four social behaviors and improved two of the three areas of academic functioning. Dose effects were present for three of the seven dependent measures. Individual analyses indicated a therapeutic response rate between 39% and 100% across dependent measures. Furthermore, individual analyses of response indicated that across several important dependent measures, 39% to 98% of children showed little incremental improvement with the higher dose compared with the lower dose of stimulant medication. Conclusions: Stimulant medication is an effective treatment for young children diagnosed with ADHD; however, multiple domains of functioning must be assessed to determine the most effective dose for young children with ADHD. J. Am. Acad. Child Adolesc. Psychiatry, 2005;44(3):249-257.

Child and Adolescent Mental Health, 1999

Many studies have demonstrated the short-term efficacy of stimulant drugs in decreasing the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). However, long-term studies have not shown a similar effect. In this study, we report an audit of the medium-term outcome of 50 children with ADHD referred to a mental health service and treated with stimulants for at least 6 months. A poor outcome group was identified consisting of 30 % of the children. As a group, they received a significantly higher dose of stimulant. More studies, with prospective design, are required to examine the medium-term outcome of children with ADHD on medication.

European Journal of Clinical Pharmacology, 2007

Objective Our objective was to evaluate the long-term impact of n-of-1 trials-within-patient randomised, double-blind, cross-over comparisons of stimulant versus placebo or stimulant-on ADHD management. Methods Telephone surveys at 3, 6 and 12 months. Main outcome measures included (1) changes in treatment before and after the n-of-1 trial, (2) congruence of management at follow-up with trial result, (3) reasons for any noncongruence, and (4) persistence of the joint patient-doctor decision over 12 months. Patients were children with clinically diagnosed ADHD, aged 5-16 years. Results A total of 76 patients were followed up; 12 months' data were available for 67 (88%). Management changed from baseline for 46, 48 and 51% at 3, 6 and 12 months respectively. Most responders, 21/37 (57%), remained on the same stimulant at 12 months, compared to 9/24 (37%) non-responders. Of the remaining non-responders, 15/24 (62%) either switched (2/24, 8%) or ceased stimulants (13/ 24, 54%). The rate of congruence with the test result was 45/65 (69%) at 3 months, 44/67 (66%) at 6 months and 40/ 67 (60%) at 12 months. Persistence with the post-trial decision over 12 months was high (79-85%) whether the decision was to continue or to cease stimulants. Conclusions Although not conclusive because there was no control group, our results suggest that n-of-1 trials may improve rational treatment of ADHD.

European Child & Adolescent Psychiatry, 2010

Attention-deficit/hyperactivity disorder (ADHD), one of the most common neuropsychiatric conditions of childhood, often has a chronic course and persists into adulthood in many individuals. ADHD may have a clinically important impact on health-related quality of life in children, a significant impact on parents’ emotional health and interfere with family activities/cohesion. To date, the main targets of ADHD treatment have focused on reducing the severity of symptoms during the school day and improving academic performance. However, the treatment of ADHD should reach beyond symptom control to address the issues of social competencies and improvement of health-related quality of life from the perspectives of individuals with ADHD and their families, to support them in reaching their full developmental potential. Methylphenidate (MPH) is recognised as the first-line choice of pharmacotherapy for ADHD in children and adolescents. This paper focuses on the importance and benefits to chi...

Clinical Child and …, 2000

Studies examining interventions for adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) were reviewed to evaluate their efficacy. These efficacy findings were supplemented with a preliminary system for judging safety and practicality. Results suggest that the stimulant drug methylphenidate (MPH) is safe and well-established empirically, but has some problems with inconvenience and noncompliance. Preliminary research supports the efficacy, safety, and practicality of some psychotherapeutic interventions, including behavioral classroom interventions, note-taking training, and family therapy. Treatment with tricyclic antidepressants was judged to have minimal empirical support and debatable safety. Very little is known about long-term effectiveness of treatments, long-term compliance, or multimodal treatments for adolescents such as stimulants plus behavior therapy.

Journal of Child and Adolescent Psychopharmacology, 2008

Background and purpose: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent disorder that can respond dramatically to medication, if dose is appropriately titrated. Studies suggest that computer measures of attention cannot be used for titration as they show improvement on doses too low to produce clinical benefits. We assessed whether measures of motor activity and attention using the McLean Motion Attention Test (M-MAT™) could identify doses associated with optimal clinical response. Methods: Eleven boys (9.6 Ϯ 1.8 years), receiving treatment with methylphenidate, and meeting DSM-IV criteria for ADHD, participated in this triple-blind (parent, child, rater), within-subject, efficacy study. Subjects received 1 week each of placebo, low (0.4 mg/kg), medium (0.8 mg/kg), and high (1.5 mg/kg) daily doses of methylphenidate. Parents rated response using an index of clinical global improvement. Results: In 9/11 subjects, the dose that produced the best improvement on M-MAT™ measures was also the dose that produced the best clinical outcome (p Ͻ 10 Ϫ5). Parents rated response to this dose significantly better than response to previously prescribed treatment. Objective measures of primarily activity and secondarily attention responded to treatment in a manner concordant with clinical ratings, suggesting that these measures have ecological validity, and the potential to facilitate medication management and titration.