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

Sponsor

Sheba Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02063945

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

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

Detailed Description

Secondary study aims:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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: 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 As stated in arm/group Other Names: Risperdal

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:

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

As stated in arm/group

Other Names:

Risperdal

Outcome Measures

Primary Outcome Measures

Change from baseline of aggressive behaviors. [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 [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 [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 [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 [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) [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 [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 [baseline, 2 weeks, 4 weeks, 8 weeks.]
Blood Tests [baseline, 8 weeks.]
Electrolytes, liver function tests, creatinine, Prolactin, complete blood count.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.