A Phase 4 interventional study of Methylphenidate and Risperidone in Attention Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder and Conduct Disorder, sponsored by Sheba Medical Center. Terminated at 1 site in Israel. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Sheba Medical Center · Phase 4, Interventional, and Treatment
Attention Deficit/Hyperactivity Disorder (ADHD) is one the most prevalent mental disorders among children and adolescents, with a prevalence of 5% in western culture. The basics of the disorder: inattentive and hyperactive/impulsive behaviors that manifest in a variety of settings causing a dysfunction in everyday life. ADHD can be subdivided into three sub-types: predominantly inattentive, predominantly hyperactive/impulsive or combined type. Common co-morbidities of ADHD are disruptive disorders; Oppositional defiant disorder (ODD) being the major one with about half of children with the combined sub-type ADHD and about a quarter of children with the predominantly inattentive also suffering from ODD. Conduct disorder is a co-morbidity for about a quarter of children with the combined sub-type ADHD. The co-occurrence of these disorders is thought to have a negative effect on the outcome of both of them.
Methylphenidate (MPH), short or long acting, is the mainstay of medical treatment for ADHD patients, it's efficacy proven in a variety of studies. It should be noted that MPH has also been proven to have a beneficial effect on children with disruptive behaviors. For children with disruptive disorders Risperidone is the mainstay of medical treatment, and has been proven in clinical trials.
To the best of their knowledge, a "head to head" study comparing these two drugs for the treatment of pediatric patients with ADHD and co-morbidity of disruptive disorders was never done before. The investigators aim is to examine the efficacy and tolerability of MPH vs. Risperidone in this population. In addition, the investigators will apply DSM5's cross cutting symptom measures scales is order to further define this unique subset of patients.
Disruptive mood dysregulation disorder (DMDD) is a new diagnosis in the latest version of the diagnostic and statistical manual (DSM5). It's main features: sever recurrent temper outbursts that are inconsistent with developmental level and occur on average three times a week, the outbursts occur in at least two settings and the mood between outbursts is irritable or angry. This diagnosis is in the differential diagnosis of ADHD with disruptive disorders.
Secondary study aims:
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 5 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will be given either "Concerta" - a long acting (12 hours) Methylphenidate pill - once daily, in the morning (starting dose 1 mg/kg, max dose 2 mg/kg), or "Ritalin LA" - a long acting (10 hours) Methylphenidate pill - once daily, in the morning (starting dose 0.6 mg/kg, max dose 1.5 mg/kg) for children who can not swallow pills.
Drug: Methylphenidate
Participants in this arm will be given a low dose of Risperidone. Starting dose will be 0.5 mg/d, max dose will be 2 mg/d.
Drug: Risperidone
As stated in arm/group
Also known as: Ritalin, Ritalin SR, Ritalin LA, Concerta
As stated in arm/group
Also known as: Risperdal
Change from baseline of aggressive behaviors.
The Retrospective Modified Overt Aggression Scale (R-MOAS) will be used for the the assessment of aggressive behaviors and their response to treatment.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Clinical Global Impression - Improvement scale (CGI-I) questionnaire
The Clinical Global Impression - Improvement scale (CGI-I) is a scale used for the assessment of overall symptom change.
Time frame: 2 weeks, 4 weeks, 8 weeks.
ADHD-RS questionnaire
The ADHD Rating Scale (ADHD-RS) is a routinely use questionnaire used for the assessment of ADHD symptomatology and it's response to treatment.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Children's Depression Rating Scale (CDRS) questionnaire
The Children's Depression Rating Scale (CDRS) is a routinely use questionnaire used for the assessment of depression symptomatology and it's response to treatment.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Young Mania Rating Scale (YMRS) questionnaire
The Young Mania Rating Scale (YMRS) is a routinely use questionnaire used for the assessment of mania symptomatology and it's response to treatment.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Children Sleep Habits Questionnaire (CSHQ)
The Children Sleep Habits Questionnaire (CSHQ) is a routinely use questionnaire used for the assessment of children sleep habits.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Clinical Global Impression - Severity (CGI-S) questionnaire
The Clinical Global Impression - Severity scale (CGI-S) is a scale used for the assessment of overall symptom severity.
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Height and Weight
Time frame: baseline, 2 weeks, 4 weeks, 8 weeks.
Blood Tests
Electrolytes, liver function tests, creatinine, Prolactin, complete blood count.
Time frame: baseline, 8 weeks.
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Methylphenidate · Risperidone
Attention Deficit Disorder with Hyperactivity →