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A Study of Combination Therapy in Children With ADHD

NCT01940978 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-04-10

No results posted yet for this study

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

DRUG

Methylphenidate ER

Watson generic, starting dose 18mg QD

DRUG

Cyproheptadine

cyproheptadine hydrochloride

Sponsors & Collaborators

  • Douglas Sears

    lead INDIV

Principal Investigators

  • Jose M Schuster, MD · SMRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940978 on ClinicalTrials.gov