NCT00191698

Brief Summary

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Typical duration for phase_3

Geographic Reach
8 countries

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

Study Start

First participant enrolled

December 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.5 years

First QC Date

September 12, 2005

Last Update Submit

October 29, 2008

Conditions

Attention Deficit Hyperactivity DisorderOppositional Defiant Disorder

Outcome Measures

Primary Outcomes (1)

  • Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo

    over 8 weeks

Secondary Outcomes (7)

  • Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo

    over 8 weeks

  • Mean change in ratings on the Oppositional subscale of the SNAP-IV

    over 8 weeks

  • Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.

    over 4 weeks

  • Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).

    over 8 weeks

  • Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).

    over 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

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

Drug: atomoxetine hydrochloride

B

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

atomoxetine hydrochlorideDRUG
Also known as: LY139603, Strattera
A
placeboDRUG
B

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

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, New South Wales, 2287, Australia

Location

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, Victoria, 3052, Australia

Location

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.

Antwerp, 2020, Belgium

Location

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.

Brussels, 1200, Belgium

Location

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.

Leuven, 3000, Belgium

Location

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.

Risskov, 8240, Denmark

Location

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.

Helsinki, 00290, Finland

Location

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.

Mannheim, 68159, Germany

Location

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.

Ulm, D-89075, Germany

Location

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.

Nijmegen, 6500 HB, Netherlands

Location

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.

Utrecht, 3584 CS, Netherlands

Location

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.

Barcelona, Barcelona, 08035, Spain

Location

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.

Tarrasa, Barcelona, Spain

Location

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.

Pamplona, Navarre, 31008, Spain

Location

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.

Dundee, Augus, DD36HH, United Kingdom

Location

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.

Edinburgh, EH9 1LL, United Kingdom

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

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityOppositional Defiant Disorder

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

December 1, 2003

Primary Completion

June 1, 2005

Study Completion

November 1, 2007

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

NL(2)DE(2)BE(3)DK(1)AU(2)GB(2)FI(1)ES(3)