Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00191698




Registration number
NCT00191698
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
31/10/2008

Titles & IDs
Public title
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
Scientific title
A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder
Secondary ID [1] 0 0
B4Z-MC-LYBX
Secondary ID [2] 0 0
7068
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 0 0
Oppositional Defiant Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: A - Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year

Placebo comparator: B - Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo
Timepoint [1] 0 0
over 8 weeks
Secondary outcome [1] 0 0
Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo
Timepoint [1] 0 0
over 8 weeks
Secondary outcome [2] 0 0
Mean change in ratings on the Oppositional subscale of the SNAP-IV
Timepoint [2] 0 0
over 8 weeks
Secondary outcome [3] 0 0
Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.
Timepoint [3] 0 0
over 4 weeks
Secondary outcome [4] 0 0
Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).
Timepoint [4] 0 0
over 8 weeks
Secondary outcome [5] 0 0
Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).
Timepoint [5] 0 0
over 8 weeks
Secondary outcome [6] 0 0
Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).
Timepoint [6] 0 0
8 weeks, 12 weeks
Secondary outcome [7] 0 0
Adverse events (AEs)
Timepoint [7] 0 0
over 1 year

Eligibility
Key inclusion criteria
* Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
* Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
* If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
* Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
* Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patients who weigh less than 20 kg or greater than 60 kg at study entry.
* Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
* Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
* Patients with a history of any seizure disorder.
* Patients determined by the investigator to be at serious suicidal risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. - Wallsend
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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. - Parkville
Recruitment postcode(s) [1] 0 0
2287 - Wallsend
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Denmark
State/province [4] 0 0
Risskov
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Germany
State/province [6] 0 0
Mannheim
Country [7] 0 0
Germany
State/province [7] 0 0
Ulm
Country [8] 0 0
Netherlands
State/province [8] 0 0
Nijmegen
Country [9] 0 0
Netherlands
State/province [9] 0 0
Utrecht
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Navarra
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Augus
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00191698