Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191542
• Other study ID #: 6671
• Secondary ID: B4Z-SO-LY15
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 10, 2006
• Start date: March 2005
• Est. completion date: August 2006

Study information

• Verified date: October 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine

• Placebo

Locations

Country	Name	City	State
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	Molnlycke
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	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	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	Vaxjo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the hypothesis that atomoxetine and psychoeducation given for 10 weeks is superior to placebo and psychoeducation in improving overall
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	To investigate if the results are modified by comorbid and/or developmental problems as measured by the "Five to Fifteen" (FTF) and K-SADS.
Secondary	To assess the long-term safety of atomoxetine.
Secondary	To assess the utilization of resources and costs to families and society between atomoxetine and placebo
Secondary	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)