NCT00546910|CompletedPhase 4Results

Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Randomized, Double Blind Comparison of the Effects of Atomoxetine Versus Placebo on Neuropsychological Outcomes Across the Day in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) by Use of a Computer Based Continuous Performance Test (cb CPT)

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

11148B4Z-SB-LYDV

Study Type

interventional

Target

125

Locations

1 country

Sites

Timeline

RegisteredOct 2007

StartedOct 2007

CompletionMay 2009

Brief Summary

This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

125

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Oct 2007

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

October 1, 2007

Completed

16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 23, 2010

Completed

Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

1.6 years

First QC Date

October 17, 2007

Results QC Date

May 21, 2010

Last Update Submit

August 4, 2010

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (4)

Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Baseline, 8 weeks (W8)
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Baseline, 8 weeks
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Baseline, 8 weeks
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Baseline, 8 weeks

Secondary Outcomes (3)

Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
Baseline, 8 weeks
Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
Baseline, 8 weeks
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Baseline, 8 weeks

Study Arms (2)

Atomoxetine

EXPERIMENTAL

0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine

Drug: Placebo

Interventions

AtomoxetineDRUG

A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.

Also known as: LY139603

Atomoxetine

PlaceboDRUG

3 capsules of placebo have to be taken once daily in the morning, with or without food.

Placebo

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
Diagnosis of ADHD
Normal intelligence
Able to swallow capsules

You may not qualify if:

Weight less than 20 kg or more than 60 kg at study entry
Prior treatment with atomoxetine
History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
History of severe allergies or multiple adverse drug reactions
Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (16)

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.

Berlin, 12589, Germany

Location

Cologne, D-50931, Germany

Location

Datteln, 45711, Germany

Location

Dorsten, 46282, Germany

Location

Düsseldorf, 40215, Germany

Location

Eberswalde, 16225, Germany

Location

Freiburg im Breisgau, 79104, Germany

Location

Fulda, 36037, Germany

Location

Giessen, 35390, Germany

Location

Hagen, 58093, Germany

Location

Hanover, 30449, Germany

Location

Kehl, 77694, Germany

Location

Mannheim, 68159, Germany

Location

München, 80639, Germany

Location

Solingen, 42719, Germany

Location

Wolfenbüttel, 38300, Germany

Location

Related Publications (1)

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: 25019647DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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 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: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 10, 2010

Results First Posted

June 23, 2010

Record last verified: 2010-08

Locations

DE(16)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (2)

Atomoxetine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations