NCT01940978

A Study of Combination Therapy in Children With ADHD

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Douglas Sears · Individual
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder With Hyperactivity
• Mental Disorders Diagnosed in Childhood
• Attention Deficit and Disruptive Behavior Disorders

Interventions

Type	Name	Description
DRUG	Methylphenidate ER	Watson generic, starting dose 18mg QD
DRUG	Cyproheptadine	cyproheptadine hydrochloride

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-09-12
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States