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

March 17, 2020 updated by: Prof. Doron Gothelf MD, Sheba Medical Center

The Assessment of Efficacy and Tolerability of Methylphenidate vs. Risperidone in the Treatment of Children and Adolescents With ADHD and Disruptive Disorders

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
As stated in arm/group
Other Names:
  • Concerta
  • Ritalin
  • Ritalin LA
  • Ritalin SR
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
As stated in arm/group
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 2 weeks, 4 weeks, 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks, 4 weeks, 8 weeks.
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.
baseline, 2 weeks, 4 weeks, 8 weeks.
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.
baseline, 2 weeks, 4 weeks, 8 weeks.
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.
baseline, 2 weeks, 4 weeks, 8 weeks.
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.
baseline, 2 weeks, 4 weeks, 8 weeks.
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.
baseline, 2 weeks, 4 weeks, 8 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height and Weight
Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks.
baseline, 2 weeks, 4 weeks, 8 weeks.
Blood Tests
Time Frame: baseline, 8 weeks.
Electrolytes, liver function tests, creatinine, Prolactin, complete blood count.
baseline, 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Doron Gothelf, professor, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0564-DG-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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