MedDataX Logo

Evaluation of Continuous Symptom Treatment of ADHD

NCT ID: NCT00486122

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atomoxetine Hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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.

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25019647 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19858759 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19420182 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B4Z-US-LYCC

Identifier Type: -

Identifier Source: secondary_id

7972

Identifier Type: -

Identifier Source: org_study_id