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

NCT00191906 | Completed Phase 4 Results

• 2 other identifiers: 7955B4Z-MC-LYCK
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm

  SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.

  Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Secondary Outcomes (15)

• Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset

  Baseline and 4 weeks of therapy

• Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset

  Baseline and 4 weeks of therapy

• Lexical Decision Task Mean Reaction Time: Correct Words

  Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

• Lexical Decision Task Mean Reaction Time: Pseudo Words

  Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

• Working Memory by Corsi Block Tapping Test (CBTT)

  Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Study Arms (4)

Atomoxetine first, then Placebo

EXPERIMENTAL

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

Drug: Atomoxetine Hydrochloride; Drug: placebo

Placebo first, then Atomoxetine

EXPERIMENTAL

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

Drug: Atomoxetine Hydrochloride; Drug: placebo

Normal Control

NO INTERVENTION

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.

Reading Disordered Control

NO INTERVENTION

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

Interventions

Atomoxetine Hydrochloride DRUG

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

Also known as: LY139603, Strattera

Atomoxetine first, then Placebo; Placebo first, then Atomoxetine

placebo DRUG

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

Atomoxetine first, then Placebo; Placebo first, then Atomoxetine

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

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, 9000, Belgium

Location

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, 1311 RL, Netherlands

Location

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, 1081 BT, Netherlands

Location

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, 4819 EV, Netherlands

Location

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, 5260 GB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 25019647 DERIVED

• 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.

  PMID: 20035588 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Dyslexia

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

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

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 25, 2010
• Results First Posted: April 6, 2010

Record last verified: 2010-05

Locations

BE (1); NL (4)