Trial record 17 of 37 for:    teen AND (violence OR aggression) | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Prof. Doron Gothelf MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02063945
First received: February 11, 2014
Last updated: February 13, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Sheba Medical Center:

Primary Outcome Measures:
  • Change from baseline of aggressive behaviors. [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Blood Tests [ Time Frame: baseline, 8 weeks. ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: February 11, 2014
Last Updated: February 13, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
ADHA
ODD
Conduct disorder
Aggression
Treatment
Methylphenidate
Risperidone

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Risperidone
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on August 21, 2014