Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

Phase 1

• Conditions: Attention-Deficit/Hyperactivity Disorder; MedDRA version: 23.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000739-15-Outside-EU/EEA
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-02
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
•patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
•child or adolescent patients must be 10 to 16 years old
•must be able to communicate in English
•must be able to swallow capsules
•be reliable to keep appointments for clinic visits and all related tests

Are the trial subjects under 18? yes
Number of subjects for this age range: 209
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•patients who weigh less than 25 Kg or greater than 70 Kg
•patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
•patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
•females who are pregnant or breastfeeding
•patients with a history of severe allergy to more than one class of medications
•patients with documented history of bipolar I or bipolar II disorder, or psychosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified