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

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Brief Title

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

Official Title

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

Brief 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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change from baseline of aggressive behaviors.

Secondary Outcome

 Clinical Global Impression - Improvement scale (CGI-I) questionnaire

Condition

Attention Deficit/Hyperactivity Disorder

Intervention

Methylphenidate

Study Arms / Comparison Groups

 Methylphenidate
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

February 1, 2017

Completion Date

February 1, 2018

Primary Completion Date

February 1, 2018

Eligibility 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.
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Doron Gothelf, professor, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02063945

Organization ID

SHEBA-13-0564-DG-CTIL


Responsible Party

Principal Investigator

Study Sponsor

Sheba Medical Center


Study Sponsor

Doron Gothelf, professor, Principal Investigator, Sheba Medical Center


Verification Date

March 2020