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

NCT02063945 | Terminated Phase 4

• 1 other identifier: SHEBA-13-0564-DG-CTIL
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ADHA; ODD; Conduct disorder; Aggression; Treatment; Methylphenidate; Risperidone

Outcome Measures

Primary Outcomes (1)

• Change from baseline of aggressive behaviors.

  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 Outcomes (6)

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

  2 weeks, 4 weeks, 8 weeks.

• ADHD-RS questionnaire

  baseline, 2 weeks, 4 weeks, 8 weeks.

• Children's Depression Rating Scale (CDRS) questionnaire

  baseline, 2 weeks, 4 weeks, 8 weeks.

• Young Mania Rating Scale (YMRS) questionnaire

  baseline, 2 weeks, 4 weeks, 8 weeks.

• Children Sleep Habits Questionnaire (CSHQ)

  baseline, 2 weeks, 4 weeks, 8 weeks.

Other Outcomes (2)

• Height and Weight

  baseline, 2 weeks, 4 weeks, 8 weeks.

• Blood Tests

  baseline, 8 weeks.

Study Arms (2)

Methylphenidate

ACTIVE COMPARATOR

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

Risperidone

ACTIVE COMPARATOR

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

Interventions

Methylphenidate DRUG

As stated in arm/group

Also known as: Ritalin, Ritalin SR, Ritalin LA, Concerta

Methylphenidate

Risperidone DRUG

As stated in arm/group

Also known as: Risperdal

Risperidone

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Tel Litwinsky, Israel

Location

Related Publications (9)

• Connor DF, Steeber J, McBurnett K. A review of attention-deficit/hyperactivity disorder complicated by symptoms of oppositional defiant disorder or conduct disorder. J Dev Behav Pediatr. 2010 Jun;31(5):427-40. doi: 10.1097/DBP.0b013e3181e121bd.

  PMID: 20535081 BACKGROUND

• Hodgkins P, Shaw M, Coghill D, Hechtman L. Amfetamine and methylphenidate medications for attention-deficit/hyperactivity disorder: complementary treatment options. Eur Child Adolesc Psychiatry. 2012 Sep;21(9):477-92. doi: 10.1007/s00787-012-0286-5. Epub 2012 Jul 5.

  PMID: 22763750 BACKGROUND

• Subcommittee on Attention-Deficit/Hyperactivity Disorder; Steering Committee on Quality Improvement and Management; Wolraich M, Brown L, Brown RT, DuPaul G, Earls M, Feldman HM, Ganiats TG, Kaplanek B, Meyer B, Perrin J, Pierce K, Reiff M, Stein MT, Visser S. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011 Nov;128(5):1007-22. doi: 10.1542/peds.2011-2654. Epub 2011 Oct 16.

  PMID: 22003063 BACKGROUND

• Seida JC, Schouten JR, Boylan K, Newton AS, Mousavi SS, Beaith A, Vandermeer B, Dryden DM, Carrey N. Antipsychotics for children and young adults: a comparative effectiveness review. Pediatrics. 2012 Mar;129(3):e771-84. doi: 10.1542/peds.2011-2158. Epub 2012 Feb 20.

  PMID: 22351885 BACKGROUND

• Poznanski EO, Cook SC, Carroll BJ. A depression rating scale for children. Pediatrics. 1979 Oct;64(4):442-50.

  PMID: 492809 BACKGROUND

• Youngstrom EA, Danielson CK, Findling RL, Gracious BL, Calabrese JR. Factor structure of the Young Mania Rating Scale for use with youths ages 5 to 17 years. J Clin Child Adolesc Psychol. 2002 Dec;31(4):567-72. doi: 10.1207/S15374424JCCP3104_15.

  PMID: 12402575 BACKGROUND

• Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.

  PMID: 11145319 BACKGROUND

• Harris S, Oakly C, Picchioni M. Quantifying Violence in Mental Health Research. Aggression and Violent Behavior 18(6):695-701, 2013.

  BACKGROUND

• Armenteros JL, Lewis JE, Davalos M. Risperidone augmentation for treatment-resistant aggression in attention-deficit/hyperactivity disorder: a placebo-controlled pilot study. J Am Acad Child Adolesc Psychiatry. 2007 May;46(5):558-565. doi: 10.1097/chi.0b013e3180323354.

  PMID: 17450046 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Oppositional Defiant Disorder; Conduct Disorder; Aggression

Interventions

Methylphenidate; Risperidone

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines

Study Officials

• Doron Gothelf, professor

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of child and adolescent psychiatry unit

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

IL (1)