Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

NCT ID: NCT00191906

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-12-31

Brief Summary

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Conditions

Attention Deficit Hyperactivity Disorder; Reading Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atomoxetine first, then Placebo

Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks

Group Type: EXPERIMENTAL

Atomoxetine Hydrochloride

Intervention Type: DRUG

Atomoxetine, 1.2 mg/kg/day, by mouth (PO)

placebo

Intervention Type: DRUG

Placebo, every day (QD), by mouth (PO)

Placebo first, then Atomoxetine

Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks

Group Type: EXPERIMENTAL

Atomoxetine Hydrochloride

Intervention Type: DRUG

Atomoxetine, 1.2 mg/kg/day, by mouth (PO)

placebo

Intervention Type: DRUG

Placebo, every day (QD), by mouth (PO)

Normal Control

Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reading Disordered Control

The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Atomoxetine Hydrochloride

Atomoxetine, 1.2 mg/kg/day, by mouth (PO)

Intervention Type: DRUG

placebo

Placebo, every day (QD), by mouth (PO)

Intervention Type: DRUG

Other Intervention Names

LY139603; Strattera

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder

Exclusion Criteria

• Patients with Conduct Disorder
• Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
• Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 . Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ghent, , Belgium

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Almere Stad, , Netherlands

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Amsterdam, , Netherlands

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Breda, , Netherlands

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Vught, , Netherlands

Countries

Belgium; Netherlands

References

Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.

Reference Type: DERIVED

PMID: 25019647 (View on PubMed)

de Jong CG, Van De Voorde S, Roeyers H, Raymaekers R, Allen AJ, Knijff S, Verhelst H, Temmink AH, Smit LM, Rodriques-Pereira R, Vandenberghe D, van Welsen I, ter Schuren L, Al-Hakim M, Amin A, Vlasveld L, Oosterlaan J, Sergeant JA. Differential effects of atomoxetine on executive functioning and lexical decision in attention-deficit/hyperactivity disorder and reading disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):699-707. doi: 10.1089/cap.2009.0029.

Reference Type: DERIVED

PMID: 20035588 (View on PubMed)

Other Identifiers

B4Z-MC-LYCK

Identifier Type: OTHER

Identifier Source: secondary_id

7955

Identifier Type: -

Identifier Source: org_study_id