An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

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Brief Title

An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

Official Title

An Italian Randomised, Double-blind Placebo Controlled Study of the Efficacy of Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Brief Summary

      The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric
      patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD).
      The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and
      ODD symptoms in patients non responders to a previous psychological intervention with parent
      support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid
      conditions associated with ADHD and ODD will be assessed.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale

Secondary Outcome

 Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity

Condition

Attention Deficit Hyperactivity Disorder

Intervention

atomoxetine 0.5 mg/kg/day

Study Arms / Comparison Groups

 Atomoxetine
Description:  atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.

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

139

Start Date

October 2004

Completion Date

May 2008

Primary Completion Date

August 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Child or adolescent patients, male or female outpatients, who are at least 6 years of
             age, but must not yet have reached their 16th birthday prior to Visit 1, when informed
             consent is obtained.

          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least
             1.5 standard deviations above the age norm for their diagnostic subtype using
             published norms for the Swanson, Nolan and Pelham Questionnaire:
             Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1
             and 2.

          -  They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and
             Visit 2.

          -  Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the
             patient's primary diagnosis.

          -  Patients must be of normal intelligence in the judgment of the investigator (that is,
             without a general impairment of intelligence and likely, in the investigator's
             judgement, to achieve a score of greater than or equal to 70 on an Intelligence
             Quotient (IQ) test). The administration of a formal IQ test is not an entry
             requirement for the study. Specific learning disabilities are not considered general
             impairment of intelligence.

        Exclusion Criteria:

          -  Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).

          -  Patients who have a documented history of Bipolar I or II disorder, any history of
             psychosis or pervasive development disorder.

          -  Patients with a history of any seizure disorder (other than febrile seizures) or
             patients who have taken (or are currently taking) anticonvulsants for seizure control
             are not eligible to participate.

          -  Patients at serious suicidal risk as assessed by the investigator.

          -  Patients who, in the investigator's judgment, are likely to need psychotropic
             medications apart from the drug under the study, including health-food supplements
             that the investigator feels have central nervous system activity (for example, St.
             John's Wort, melatonin).
      

Gender

All

Ages

6 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

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 ), , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00192023

Organization ID

8856

Secondary IDs

B4Z-IT-LYCY


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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST ), Study Director, Eli Lilly and Company


Verification Date

December 2009