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Major difficulties recruiting participants
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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.
Secondary study aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | As stated in arm/group |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Improvement scale (CGI-I) questionnaire | The Clinical Global Impression - Improvement scale (CGI-I) is a scale used for the assessment of overall symptom change. | 2 weeks, 4 weeks, 8 weeks. |
| ADHD-RS questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Height and Weight | baseline, 2 weeks, 4 weeks, 8 weeks. | |
| Blood Tests | Electrolytes, liver function tests, creatinine, Prolactin, complete blood count. | baseline, 8 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doron Gothelf, professor | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Tel Litwinsky | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20535081 | Background | 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. | |
| 22763750 | 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. |
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| Risperidone | Drug | As stated in arm/group |
|
|
The ADHD Rating Scale (ADHD-RS) is a routinely use questionnaire used for the assessment of ADHD symptomatology and it's response to treatment.
| baseline, 2 weeks, 4 weeks, 8 weeks. |
| Children's Depression Rating Scale (CDRS) questionnaire | 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. | baseline, 2 weeks, 4 weeks, 8 weeks. |
| Young Mania Rating Scale (YMRS) questionnaire | The Young Mania Rating Scale (YMRS) is a routinely use questionnaire used for the assessment of mania symptomatology and it's response to treatment. | baseline, 2 weeks, 4 weeks, 8 weeks. |
| Children Sleep Habits Questionnaire (CSHQ) | The Children Sleep Habits Questionnaire (CSHQ) is a routinely use questionnaire used for the assessment of children sleep habits. | baseline, 2 weeks, 4 weeks, 8 weeks. |
| Clinical Global Impression - Severity (CGI-S) questionnaire | The Clinical Global Impression - Severity scale (CGI-S) is a scale used for the assessment of overall symptom severity. | baseline, 2 weeks, 4 weeks, 8 weeks. |
| 22003063 | 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. |
| 22351885 | 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. |
| 492809 | Background | Poznanski EO, Cook SC, Carroll BJ. A depression rating scale for children. Pediatrics. 1979 Oct;64(4):442-50. |
| 12402575 | 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. |
| 11145319 | 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. |
| Background | Harris S, Oakly C, Picchioni M. Quantifying Violence in Mental Health Research. Aggression and Violent Behavior 18(6):695-701, 2013. |
| 17450046 | 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. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000096865 | Oppositional Defiant Disorder |
| D019955 | Conduct Disorder |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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