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A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents

NCT01127646 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-11-28

Study results available
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Summary

The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Atomoxetine

25-80 milligrams (mg) administered orally, once daily.

DRUG

Osmotic-release oral system methylphenidate

18-54 mg administered orally, once daily.

DRUG

Placebo

Administered orally, once daily for random nonconsecutive 6 days during 4-week treatment period.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Netherlands
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01127646 on ClinicalTrials.gov