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Methylphenidate Study in Young Children With Developmental Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00517504
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : July 4, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE August 15, 2007
First Posted Date  ICMJE August 17, 2007
Last Update Posted Date July 4, 2012
Study Start Date  ICMJE May 2001
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2007)
- Hyperactive-Impulsive subscale of the Conners Rating Scale-Revised completed at baseline and at each week of the drug trial. - Clinician's Global Improvement completed at baseline and at each week of the drug trial. [ Time Frame: 3 to 4.5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2007)
-Hyperactive subscale of the Nisonger-Child Behavior Rating Form. -Children's Global Assessment Scale -Weekly side effect ratings and safety measures -Behavioral observation -Neuropsychological executive functions -Childhood Autism Rating Scale [ Time Frame: 3 to 4.5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate Study in Young Children With Developmental Disorders
Official Title  ICMJE Methylphenidate Study in Young Children With Developmental Disorders
Brief Summary The purpose of this study is to determine if methylphenidate (a common brand name is Ritalin), a medicine used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of ADHD in young children with Developmental Disorders (DD)
Detailed Description

Currently, there is no systematic empirical information to guide the use of methylphenidate (a common brand name is Ritalin) to treat symptoms of ADHD in young children with Autistic Disorder/Asperger's Disorder/Pervasive Developmental Disorder, Not Otherwise Specified/Developmental Disorders. Preliminary data from a recent study of ADHD in young children suggest that methylphenidate may be useful in children with developmental disorders (DD). The purpose of this study is to determine the safety and efficacy of methylphenidate to treat ADHD symptoms in young children with Pervasive Developmental Disorders (PDD) or Developmental Disorders (DD).

All subjects will be screened for eligibility inclusion and exclusion criteria. All concurrent non-pharmacological therapies will be stabilized for a minimum period of 2 weeks prior to the child's entry into the drug phase of the study. At each medication follow-up visit, a detailed history will be obtained and recorded for all concurrent treatments. If a child enrolls in this study, his/her participation will last approximately 3 to 4½ months with 12-18 outpatient daytime visits.

Screening assessment: The child's parent and teacher/daycare provider, if applicable, will need to complete some forms that describe the child's problems with overactivity, impulsivity and inattention. If these forms indicate that the child may have ADHD the investigator will schedule outpatient-screening assessments. The research staff will evaluate the child to see if s/he has a Developmental Disorder (DD) or PDD and ADHD. Each child will receive a developmental assessment, and each parent will be interviewed about his or her child's behavior. The child's teacher will be given several rating forms to complete. The parents will be asked to complete some questions about the child's development. Both parents (if available) will be interviewed about their family histories. Some of the screening assessments will be videotaped/audiotaped. Each child will have a physical examination, an electrocardiogram (EKG), a urine test and a blood test. The doctor will ask the parents about his or her child's medical history.

Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. Each child will first have a step-wise single-blind titration of MPH to determine his/her best dose followed by a double-blind crossover trial with placebo and the child's best dose. The order of active drug and placebo will be randomized across the sample so that half the children will first receive MPH for 2 weeks and the other half will first receive placebo for 2 weeks. The children will receive the alternative drug condition (placebo or the child's best dose) for the next 2 weeks.

The child and his/her parents will come back each week for a clinic visit. At each visit the child's height, weight, blood pressure and pulse will be checked. The child's parents and teacher/daycare provider, if applicable, will be asked to complete some rating scales every week.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE Drug: Methylphenidate
  • 1-week single blind placebo lead-in phase.
  • step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week.

Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects.

After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control.

Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2012)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2007)
50
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 36-84 month old children
  • Child must meet the DSM-IV criteria for AD or PDD NOS as determined via a parent interview on the ADI-R and on child observation via the ADOS, or DD.
  • Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months

Exclusion Criteria:

  • Child with prior failed treatment with an adequate trial of methylphenidate;
  • Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics);
  • Child with a current history of chronic tic disorder (e.g., Tourette syndrome with current severity of moderate or more), or a family history of Tourette's Disorder. Children with chronic mild tics will be eligible for the study;
  • Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by methylphenidate (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization). Children with seizures will be eligible for the study if the seizure medication is stable for 3 months and the child is seizure-free for at least 6 months;
  • Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, Rett's Disorder, Childhood Disintegrative Disorder, or other psychiatric disorders in addition to PDD and ADHD that may require treatment with additional/alternative medication;
  • Current history of physical, sexual, or emotional abuse;
  • The patient has taken an investigational drug within the last 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Months to 84 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00517504
Other Study ID Numbers  ICMJE HSC03-59
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Jaswinder K Ghuman, M.D. University of Arizona
PRS Account University of Arizona
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP