Clinical trial NCT00486122: Evaluation of Continuous Symptom Treatment of ADHD
Official title: Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 282
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.


Eligibility criteria: Inclusion Criteria:

* Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised
* Males or females who are at least 6 years old and no more than 12 years old prior to visit 2
* Patients must be able to swallow capsules
* Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 70 or more if formal IQ testing were administered.
* Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)

Exclusion Criteria:

* Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)
* Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis
* Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.
* Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient
* Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.

Primary outcomes:
measure: Test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD
Secondary outcomes:
measure: Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy compared with placebo in children with ADHD
measure: Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the evenings compared with placebo in children with ADHD
measure: Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD based on the CGIP-M
measure: To assess the effect of dosing atomoxetine in the morning versus placebo on measures of executive functioning
measure: Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy compared with placebo for measures of adaptive functioning in children with ADHD
measure: Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy in the evenings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
measure: Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
measure: To examine the onset of action during the first week of treatment in the morning versus in the evening versus placebo
measure: To assess the effect of dosing atomoxetine in the evening versus placebo on measures of executive functioning
measure: To compare morning versus evening dosing versus placebo as assessed by the CGI-ADHD-S
measure: To assess the safety and tolerability of atomoxetine dosed in the morning versus in the evening versus placebo
Other outcomes:
Locations:
city: Columbus
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Newcorn JH, Sutton VK, Zhang S, Wilens T, Kratochvil C, Emslie GJ, D'souza DN, Schuh LM, Allen AJ. Characteristics of placebo responders in pediatric clinical trials of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1165-72. doi: 10.1097/CHI.0b013e3181bc730d.
citation: Block SL, Kelsey D, Coury D, Lewis D, Quintana H, Sutton V, Schuh K, Allen AJ, Sumner C. Once-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosing. Clin Pediatr (Phila). 2009 Sep;48(7):723-33. doi: 10.1177/0009922809335321. Epub 2009 May 6.