Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

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Brief Title

Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

Official 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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Attention Deficit Hyperactivity Disorder

Intervention

atomoxetine hydrochloride

Study Arms / Comparison Groups

 A
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

226

Start Date

December 2003

Completion Date

November 2007

Primary Completion Date

June 2005

Eligibility Criteria

        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.

        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.
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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), , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00191698

Organization ID

7068

Secondary IDs

B4Z-MC-LYBX


Study Sponsor

Eli Lilly and Company


Study Sponsor

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), Study Director, Eli Lilly and Company


Verification Date

October 2008