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A Study of Combination Therapy in Children With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:
A Double-Blind Placebo-Controlled Study of Combination Therapy in Children With ADHD

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01940978
Study type Interventional
Source Sears, Douglas, M.D.
Contact
Status Completed
Phase Phase 4
Start date March 2014
Completion date March 2015
View Details
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