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Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Prof. Doron Gothelf MD, Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02063945
First Posted: February 17, 2014
Last Update Posted: February 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Doron Gothelf MD, Sheba Medical Center
  Purpose

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.


Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder Oppositional Defiant Disorder Conduct Disorder Drug: Methylphenidate Drug: Risperidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Assessment of Efficacy and Tolerability of Methylphenidate vs. Risperidone in the Treatment of Children and Adolescents With ADHD and Disruptive Disorders

Resource links provided by NLM:


Further study details as provided by Prof. Doron Gothelf MD, Sheba Medical Center:

Primary Outcome Measures:
  • Change from baseline of aggressive behaviors. [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    The Retrospective Modified Overt Aggression Scale (R-MOAS) will be used for the the assessment of aggressive behaviors and their response to treatment.


Secondary Outcome Measures:
  • Clinical Global Impression - Improvement scale (CGI-I) questionnaire [ Time Frame: 2 weeks, 4 weeks, 8 weeks. ]
    The Clinical Global Impression - Improvement scale (CGI-I) is a scale used for the assessment of overall symptom change.

  • ADHD-RS questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    The ADHD Rating Scale (ADHD-RS) is a routinely use questionnaire used for the assessment of ADHD symptomatology and it's response to treatment.

  • Children's Depression Rating Scale (CDRS) questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    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.

  • Young Mania Rating Scale (YMRS) questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    The Young Mania Rating Scale (YMRS) is a routinely use questionnaire used for the assessment of mania symptomatology and it's response to treatment.

  • Children Sleep Habits Questionnaire (CSHQ) [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    The Children Sleep Habits Questionnaire (CSHQ) is a routinely use questionnaire used for the assessment of children sleep habits.

  • Clinical Global Impression - Severity (CGI-S) questionnaire [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
    The Clinical Global Impression - Severity scale (CGI-S) is a scale used for the assessment of overall symptom severity.


Other Outcome Measures:
  • Height and Weight [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ]
  • Blood Tests [ Time Frame: baseline, 8 weeks. ]
    Electrolytes, liver function tests, creatinine, Prolactin, complete blood count.


Estimated Enrollment: 70
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate
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
Other Names:
  • Ritalin
  • Ritalin SR
  • Ritalin LA
  • Concerta
Active Comparator: Risperidone
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
Other Name: Risperdal

Detailed Description:

Secondary study aims:

  1. Comparing the efficacy and tolerability of MPH vs. Risperidone in the treatment of depressive symptoms in children and adolescents with ADHD and disruptive disorders.
  2. Comparing the efficacy and tolerability of MPH vs. Risperidone in the treatment of manic symptoms in children and adolescents with ADHD and disruptive disorders.
  3. Comparing the impact of MPH vs. Risperidone on overall every day functioning of children and adolescents with ADHD and disruptive disorder.
  4. Comparing the impact of MPH vs. Risperidone on nighttime sleep of children and adolescents with ADHD and disruptive disorder.
  5. Comparing the impact of MPH vs. Risperidone on weight and height of children and adolescents with ADHD and disruptive disorder.
  6. Assessing the overlap between the diagnosis of ADHD and disruptive disorders and DMDD.
  7. Assessing mood disorders and response to MPH vs. Risperidone treatment in children and adolescents with ADHD and disruptive disorder.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063945


Locations
Israel
Sheba medical center Recruiting
Tel Hashomer, Israel
Contact: Gita Veiber, Msc.    972-3-5303810    gita.veiber@sheba.health.gov.il   
Sub-Investigator: Ehud Mekori, Dr.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Doron Gothelf, professor Sheba Medical Center
  More Information

Publications:
Harris S, Oakly C, Picchioni M. Quantifying Violence in Mental Health Research. Aggression and Violent Behavior 18(6):695-701, 2013.

Responsible Party: Prof. Doron Gothelf MD, Head of child and adolescent psychiatry unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02063945     History of Changes
Other Study ID Numbers: SHEBA-13-0564-DG-CTIL
First Submitted: February 11, 2014
First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by Prof. Doron Gothelf MD, Sheba Medical Center:
ADHA
ODD
Conduct disorder
Aggression
Treatment
Methylphenidate
Risperidone

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Risperidone
Methylphenidate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators