We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Combination Therapy in Children With ADHD

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: NCT01940978
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Douglas Sears, Sears, Douglas, M.D.

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date April 10, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 0, 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
Appetite - ADAT [ Time Frame: 12 weeks ]
Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score [ Time Frame: 0,1,5,9,12 weeks ]
    The items from the DSM-IV (1994) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/ impulsivity (items #11-#19).
  • Weight [ Time Frame: 0,1,5,9,12 Weeks ]
  • Appetite - VAS - Visual Analogue Scale [ Time Frame: 0,1,5,9,12 ]
  • Clinical Global Impressions - Improvement(CGI-I): ADHD Score [ Time Frame: 1,5,9,12 weeks ]
  • Clinical Global Impressions - Severity(CGI-S): ADHD Score [ Time Frame: 0,1,5,9,12 ]
  • Clinical Global Impressions - Effectiveness(CGI-E): ADHD Score [ Time Frame: 1,5,9,12 ]
  • Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 1,5,9 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
  • Appetite - ADAT [ Time Frame: 0,1,4,8 weeks ]
    Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996).
  • DSM-IV ADHD symptom checklist (SNAP-IV) [ Time Frame: 0,1,4,8,12 weeks ]
    The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The items from the DSM-IV (1994) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/ impulsivity (items #11-#19).
  • Weight [ Time Frame: 0,1,4,8,12 Weeks ]
  • Appetite - VAS [ Time Frame: 0,1,4,8,12 ]
    VAS - Visual Analogue Scale
  • CGI-I [ Time Frame: 1,4,8,12 weeks ]
    Clinical Global Impression - Improvement scale (CGI-I)
  • CGI-S [ Time Frame: 0,1,4,8,12 ]
    Clinical Global Impression - Severity Scale (CGI-S)
  • CGI-E [ Time Frame: 1,4,8,12 ]
    Clinical Global Impression - Effectiveness Scale (CGI-E)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Combination Therapy in Children With ADHD
Official Title  ICMJE A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD
Brief Summary

Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines such as methylphenidate. Lack of sufficient food intake has been shown to have negative effects on weight and height as well as learning and memory.

There is no current treatment to prevent this loss of appetite except discontinuation or reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the return of ADHD symptoms.

The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug, cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression associated with methylphenidate.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • ADHD
  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Disorder With Hyperactivity
  • Mental Disorders Diagnosed in Childhood
  • Attention Deficit and Disruptive Behavior Disorders
Intervention  ICMJE
  • Drug: Methylphenidate ER
    Watson generic, starting dose 18mg QD
    Other Name: Concerta
  • Drug: Cyproheptadine
    cyproheptadine hydrochloride
    Other Name: Periactin
Study Arms  ICMJE
  • Placebo Comparator: Control
    Methylphenidate ER QD placebo BID
    Intervention: Drug: Methylphenidate ER
  • Active Comparator: Methylphenidate ER, cyproheptadine 2.5mg
    Methylphenidate ER QD cyproheptadine hydrochloride 2.5mg BID
    Interventions:
    • Drug: Methylphenidate ER
    • Drug: Cyproheptadine
  • Active Comparator: Methylphenidate ER, cyproheptadine 5mg
    Methylphenidate ER QD cyproheptadine hydrochloride 5.0mg BID
    Interventions:
    • Drug: Methylphenidate ER
    • Drug: Cyproheptadine
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: September 9, 2013)
99
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject and subject's parents speak English
  • Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 13th birthday prior to Visit 1, when informed consent is obtained
  • Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
  • Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
  • Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.
  • Patient has not been on stimulants for at least 2 weeks.

Exclusion Criteria:

  • Patients who have a documented history of Bipolar I or II disorder, or any history of psychosis. Diabetic patients or patients on chronic steroids.
  • Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
  • Patients at serious suicidal risk as defined by 1) suicidal ideation as endorsed on items 4 and 5 of the C-SSRS within the past year, 2) suicidal behaviors detected by the C-SSRS during the past two years; or 3) psychiatric interview and examination
  • Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
  • Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis
  • Presence of contraindications for methylphenidate or cyproheptadine hydrochloride
  • Patients who have had prior serious adverse reaction to stimulants.
  • Parental or (immediate) family history of substance abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940978
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Douglas Sears, Sears, Douglas, M.D.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Douglas Sears
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose M Schuster, MD SMRI
PRS Account Sears, Douglas, M.D.
Verification Date April 2015

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