Clinical Trial: A Study of Combination Therapy in Children With ADHD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Douglas Sears

Current Primary Outcome: Appetite - Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996) [ Time Frame: 0, 12 weeks ]

Original Primary Outcome: Appetite - ADAT [ Time Frame: 12 weeks ]

Appetite and Dietary Assessment Tool (ADAT) developed by Burrowes et al (1996).


Current Secondary Outcome:

  • 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:

  • 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)


Information By: Sears, Douglas, M.D.

Dates:
Date Received: September 9, 2013
Date Started: March 2014
Date Completion:
Last Updated: April 8, 2015
Last Verified: April 2015