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Attention Deficit/Hyperactivity Disorder | Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders

Attention Deficit/Hyperactivity Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Clinical diagnosis of ADHD (any sub-type) with oppositional defiant disorder. - Clinical diagnosis of ADHD (any sub-type) with conduct disorder. - Clinical diagnosis of other specified ADHD with oppositional defiant disorder. - Clinical diagnosis of other specified ADHD with conduct disorder. - Clinical diagnosis of unspecified ADHD with oppositional defiant disorder. - Clinical diagnosis of unspecified ADHD with conduct disorder. Exclusion Criteria: - Participant who do not qualify for inclusion criteria. - Participant who are not willing to join the study. - Epilepsy. - Neuro-genetic syndromes. - Brain tumors. - Autism. - Participants who are under psychiatric medication and have changed it (dose or kind) in the last month. - Congenital heart, kidney of liver defects. - Cardiomyopathies. - Past hypersensitivity to Methylphenidate or Risperidone.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Attention Deficit/Hyperactivity Disorder

Oppositional Defiant Disorder

Conduct Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Methylphenidate

Drug:Risperidone

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MethylphenidateParticipants 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.

RisperidoneParticipants 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.

Study Status

Unknown status

Start Date: February 2014

Completed Date: February 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change from baseline of aggressive behaviors.

Secondary Outcome: Clinical Global Impression - Improvement scale (CGI-I) questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Doron Gothelf, professor

Lead Sponsor: Sheba Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02063945

Connor DF, Steeber J, McBurnett K. A review of attention-deficit/hyperactivity disorder complicated by symptoms of oppositional defiant disorder or conduct disorder. J Dev Behav Pediatr. 2010 Jun;31(5):427-40. doi: 10.1097/DBP.0b013e3181e121bd. Review.

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