An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder with or without comorbid conditions - ND

• Conditions: Child or adolescent patients with Attention-Deficit/ Hyperactivity Disorder ADHD; MedDRA version: 6.1Level: PTClassification code 10003736

• Registration Number: EUCTR2005-005701-32-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1 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. 2 Patients must meet DSM-IV diagnostic criteria for ADHD any subtype as defined in Section 4.3.1 Disease Diagnostic Criteria and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the SNAP-IV ADHD Subscale score refer to Protocol Attachment LYDS.2 at both Visit 1 and 2. Other comorbid conditions are allowed but the diagnosis of ADHD must be the patient s primary diagnosis. 3 Laboratory results, including serum chemistries, haematology, 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 . A patients with a significant abnormal laboratory results may enter the study if, after appropriate medical evaluation, the result does not indicate a serious medical condition that in the investigator s judgment would preclude participation. If there is any question about the appropriateness of participation or relevance of a particular finding, the Lilly physician monitoring the study should be consulted. In addition, there must be no clinical information that, in the judgment of a physician, should preclude a patient s participation at study entry. 4 An 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. 5 Patients must be of normal intelligence in the judgment of the investigator 61531;that is, without a general impairment of intelligence and likely, in the investigator s judgement, to achieve a score of 70 on an Intelligence Quotient IQ test 61533;. The administration of a formal QI test is not an entry requirement for the study. Specific learning disabilities are not considered general impairment of intelligence. 6 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. 7 Patients and parents must be able to communicate effectively with the investigator and study coordinator as well as be able to complete self reported scales used in the study. 8 Patients must be able to swallow capsules.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 Patients who weigh less than 20 kg at study entry Visit 1 . 2 Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder. 3 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. 4 Patients at serious suicidal risk as assessed by the investigator. 5 Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions. 6 Patients with a history of alcohol or drug abuse within the past 3 months excessive or compulsive use as judged by the investigator , or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse. Patients who screen positive at study entry for drugs of abuse not prescribed by a physician are excluded from the study. 7 Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure. 8 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. 9 Patients with current or past history of hypertension. For the purposes of this protocol, hypertension will be defined as average systolic or diastolic blood pressure, measured on at least 2 separate occasions, greater than or equal to the 95th percentile for age and sex defined by the National Heart and Lung Institute National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents 1996 . The adequacy of historical diagnoses will be determined by the investigator. 10 Patients with Narrow Angle Angle-Closure Glaucoma 11 Patients with uncontrolled hyperthyroidism or hypothyroidism. 12 Patients who, in the investigator s judgment, are likely to need psychotropic medications apart from the drug under the study, including health-food supplements that the investigator feels have central nervous system activity for example, St. John s Wort, melatonin . 13 Patients who at any time during the study are likely to begin a structured psychotherapy are excluded. 14 Use of monoamine oxidase inhibitors MAOIs during the 2 weeks 14 days prior to Visit 2. 15 Pregnant or breastfeeding females are excluded from the study. Sexually active females who do not use a medically acceptable method of contraception oral contraception or barrier methods as condom or diaphragm combined with spermicidal agent are also excluded from the study. 16 Patients who are directly affiliated with the conduct of this study, or are immediate family of someone directly affiliated with the conduct of this study that is, Lilly employees, investigators, site personnel, or their immediate families . Immediate family is defined as child or sibling, whether biological or legally adopted. 17 Patients who have participated in a prior clinical study of atomoxetine 18 Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this stu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified