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

NCT ID: NCT02063945

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Methylphenidate

Intervention Type: DRUG

As stated in arm/group

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.

Group Type: ACTIVE_COMPARATOR

Risperidone

Intervention Type: DRUG

As stated in arm/group

Interventions

Methylphenidate

As stated in arm/group

Intervention Type: DRUG

Risperidone

As stated in arm/group

Intervention Type: DRUG

Other Intervention Names

Ritalin; Ritalin SR; Ritalin LA; Concerta; Risperdal

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.

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Doron Gothelf MD

Head of child and adolescent psychiatry unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doron Gothelf, professor

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba medical center

Tel Litwinsky, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 20535081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22763750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22003063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22351885 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 492809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12402575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11145319 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 17450046 (View on PubMed)

Other Identifiers

SHEBA-13-0564-DG-CTIL

Identifier Type: -

Identifier Source: org_study_id