A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning compared with Fast Transitioning from a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD) - LYFJ

• Conditions: Attention Deficit/Hyperactivity Disorder/ADHD; MedDRA version: 9.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorder

• Registration Number: EUCTR2008-001767-11-GB
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

[1] Parents of patients must have signed and dated the Informed consent document and assent should have been obtained from the patient (when appropriate)
[2] Patients must be male or female outpatients who must be at least 6 years of age and must not have reached their 17th birthday by Visit 1.
[3] Patients must meet the DSM-IV diagnostic criteria for ADHD (any subtype). For the purposes of this study, the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL (Section 4.1.1, Disease Diagnostic Criteria).
[4] Patients must have laboratory results, including serum chemistries, hematology, and urinalysis (see Attachment LYFJ.2) showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) and no clinical information that, in the judgment of a physician, should preclude a patient’s participation at study entry. A patient with a clinically significant abnormal laboratory result 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 clinical research physician (CRP) monitoring the study should be consulted.
[5] Patients must have an electrocardiogram (ECG) at Visit 1 with results available and reviewed prior to dispensing study drug at Visit 2. If an ECG shows an abnormality meeting one or more of the criteria in Protocol Attachment LYFJ.3, the patient must be excluded from the study. Patients with other abnormalities may be included at the discretion of the investigator; however, the Lilly CRP monitoring the study or designee must be notified.
[6] Patients and parents (or legal representative) must have an educational level and degree of understanding sufficient to communicate suitably with the investigator and study coordinator.
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[7] Patients must be of normal intelligence as assessed by the investigator (i.e., without a general impairment of intelligence and likely, in the investigator’s judgment, to achieve a score of =70 on an Intelligence Quotient [IQ] test). The administration of a formal IQ test is not an entry requirement for this study. Specific learning disabilities are not considered general impairments of intelligence.
[8] Patients and parents (or legal representative) must be judged by the investigator to be reliable to keep appointments for clinic visits.
[9] Patients must be able to swallow capsules.
[10] Only patients with unsatisfactory symptom response to stimulant therapy such that the treating physician desires to change the patient’s therapy or patients experiencing AEs while on stimulant therapy are eligible for inclusion in the study.
[11] For female patients of child-bearing potential only: Test negative for pregnancy at the time of entry (Visit 1) based on a urine pregnancy test. If local law, an ERB and/or regulatory bodies have different requirements then these requirements take precedence.
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

[12] Patients who weigh less than 20 kg or more than 70 kg at study entry.
[13] Patients who have a documented history of bipolar disorder, any history of psychosis or pervasive development disorder (autistic spectrum disorder). If the investigator believes that such a diagnosis has previously been made in error, he/she should contact Lilly and discuss the case history with the Lilly physician responsible for the study prior to allowing the patient to enter the study.
[14] 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.
[15] Patients determined by the investigator to be at serious suicidal risk.
[16] Patients with a history of severe allergies to more than one class of medications or have had multiple adverse drug reactions.
[17] Patients who have narrow angle glaucoma.
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[18] 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.
[19] Patients with acute or unstable medical conditions, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hypothyroidism or hyperthyroidism, acute systemic infection, renal insufficiency , gastroenterologic, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease should be excluded.
[20] Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
[21] Patients who have a medical condition that would markedly increase sympathetic nervous system activity (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudophedrine) having sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis.
[22] Patients who at any time during the study are likely to need psychotropic medications apart from the drugs under study, including health-food supplements that in the investigator’s opinion have central nervous system (CNS) activity (for example, St. John’s Wort, melatonin).
[23] Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 1.
[24] Patients with hypertension which is clinically significant in the opinion of the investigator or who are currently taking an antihypertensive agent for blood pressure control.
[25] Patients whose ECG at Screening shows an abnormality meeting one or more of the criteria in Protocol Attachment LYFJ.3
[26] Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[27] Pregnant or breastfeeding females are excluded from the study.
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[28] Sexually active females who do not use a medically acceptable method of contraception are also excluded from the study. For this study, medically acceptable methods of contraception include barrier methods (condom or diaphragm with spermicidal agent) or oral contraception. The rhythm method (abst

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the efficacy of 2 different switching approaches; at the end of the fast (Week 2) and slow (Week 10) transition from stimulants to atomoxetine as measured by Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator-Administered and Scored (ADHD-RS-IV Parent: Inv). The analysis will be based on the change from baseline to Weeks 2 and 10, respectively.;Secondary Objective: Please see protocol;Primary end point(s): The primary efficacy variable in this study will be the change in the ADHD-RS-IV Parent:Inv (further on referred to as ADHD-RS) at the end of fast transition (Week 2; end of fast switching) and at the end of slow transition (Week 10; end of slow switching).