Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191542

Purpose

Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation after 10 weeks of treatment

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To test the hypothesis that atomoxetine and psychoeducation given for 10 weeks is superior to placebo and psychoeducation in improving overall
functioning of patients with ADHD as measured by the mean change in the total score of the Child Health and Illness Profile-Child Edition-Parent form (CHIP-CE-Parent form) domain Achievement.

Secondary Outcome Measures:

To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD as measured by change in the CHIP-CE-Parent form domains Satisfaction, Comfort, Resilience, and Risk avoidance.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD with regard to core ADHD symptoms, as measured by the ADHDRS total score.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD with regard to severity of illness and improvement, as measured by the CGI-ADHD-S and CGI-ADHD-I.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD with regard to self-perception, as measured by the "I Think I Am" ("Jag tycker jag ar") tool.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD as measured by change in all twelve CHIP-CE-Parent form subdomains.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD as measured by change in total CHIP-CE-Parent form score.
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD with regard to family stress, as measured by the Appraisals of Stress in Child-Rearing (ASCR).
To compare the effects of atomoxetine and psychoeducation with those of placebo and psychoeducation at 10 weeks in patients with ADHD with regard to family burden of illness, as measured by the FBIM.
To investigate the concurrent validity of the FBIM and the ASCR in order to test the validity of the former instrument in a Swedish population.
To assess whether the changes in scores on the aforementioned rating scales are maintained over the longer term (at week 17, 25, 37, and 49, respectively; for "I think I am" at week 49 only).
To investigate if the results are modified by comorbid and/or developmental problems as measured by the "Five to Fifteen" (FTF) and K-SADS.
To assess the long-term safety of atomoxetine.
To assess the utilization of resources and costs to families and society between atomoxetine and placebo
during the 10 week double blind treatment period and for each patient during the following open label extension period, using the Resource Utilization Questionnaire (RUQ)

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	7 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet the criteria for ADHD of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) as well as severity criteria. Diagnosis is assessed by the investigator's clinical evaluation as well as administration of the K-SADS-PL structured interview.
Meet a symptom severity threshold of 1.5 standard deviations above age and sex norms for their diagnostic subtype on the ADHDRS-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) This severity threshold must be met at Visit 1 and maintained at Visit 2.
Be at least 7 years of age, but not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
For female subjects of child-bearing potential only, test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control.

Exclusion Criteria:

Weigh less than 20 kg at study entry
Have a documented history of Bipolar Disorder or any history of psychosis or pervasive development disorder (autistic spectrum disorder).
Are pregnant or breastfeeding.
Are at serious suicidal risk as assessed by the investigator.
Have been treated previously for ADHD with pyschostimulants such as Methylphenidate or Ritalin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191542

Locations

Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Goteborg, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Huddinge, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Linkoping, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Lund, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Uppsala, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Umea, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Vaxjo, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Orebro, Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Molnlycke, Sweden

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

No publications provided

Study ID Numbers:	6671, B4Z-SO-LY15
Study First Received:	September 12, 2005
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00191542 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on September 02, 2009