drugset / Trial / NCT01940978

A Study of Combination Therapy in Children With ADHD

NCT01940978

Phase 4 Completed 99 enrolled Douglas Sears
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-03
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyproheptadine Small molecule 2.5 mg
Comparator Cyproheptadine Small molecule 5 mg
Comparator Methylphenidate Small molecule 18 mg