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

NCT02063945 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder
  • Oppositional Defiant Disorder
  • Conduct Disorder

Interventions

DRUG

Methylphenidate

As stated in arm/group

DRUG

Risperidone

As stated in arm/group

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Doron Gothelf, professor · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063945 on ClinicalTrials.gov