Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT ID: NCT00320528

Last Updated: 2010-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-10-31

Brief Summary

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pure ADHD

Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Group Type: EXPERIMENTAL

atomoxetine

Intervention Type: DRUG

0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

ADHD+Internalizing Disorders

Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Group Type: EXPERIMENTAL

atomoxetine

Intervention Type: DRUG

0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

ADHD+Externalizing Disorders

Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Group Type: EXPERIMENTAL

atomoxetine

Intervention Type: DRUG

0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Interventions

atomoxetine

0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Intervention Type: DRUG

Other Intervention Names

LY139603; Strattera

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 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 Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
• Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant 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)
• An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
• Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Exclusion Criteria

• 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 with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
• Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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

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.

Acireale, , Italy

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.

Avellino, , Italy

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Bosisio Parini, , Italy

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Brescia, , Italy

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Catania, , Italy

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Coppito, , Italy

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Cremona, , Italy

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Milan, , Italy

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Ostuni, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Rho, , Italy

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Rome, , Italy

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Sassari, , Italy

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Savigliano, , Italy

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Siena, , Italy

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Trieste, , Italy

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Troina, , Italy

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Udine, , Italy

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Viterbo, , Italy

Countries

Italy

Other Identifiers

B4Z-IT-LYDS

Identifier Type: -

Identifier Source: secondary_id

9867

Identifier Type: -

Identifier Source: org_study_id