Attention-Deficit/Hyperactivity Disorder MedDRA version: 14.1 Level: PT Classification code 10003736 Term: Attention deficit/hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: STRATTERA
Product Name: Atomoxetine Hydrochloride
Product Code: LY139603
Pharmaceutical Form: Capsule
CAS Number: 82248-59-7
Current Sponsor code: LY139603
Other descriptive name: ATOMOXET
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Child or adolescent patients must be 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 the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision? (DSM-IV-TR?) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score ³4 at both Visit 1 and Visit 2. [3] Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM?IV-TR or International Statistical Classification of Diseases and Related Health Problems [World Health Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1. [4] Patients must be drug naive before Visit 1. Drug naive is defined as having not received more than two consecutive days of any dose of stimulants or more than 6 days consecutive of any pharmacological treatment for ADHD during the patient?s lifetime and having not received any dose of stimulant or more than 1 day on any pharmacological treatment for ADHD within 30 days before Visit 1. [5] Patients must have an electrocardiogram (ECG) at Visit 1 with results available and reviewed prior to dispensing drug at Visit 2. If an ECG shows an abnormality meeting one or more of the criteria in Protocol Attachment LYDM.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 physician monitor or designee must be notified. [6] Patients must have laboratory results, including serum chemistries, hematology, and urinalysis 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 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 physician monitoring the study should be consulted. [7] Patients must be able to swallow capsules. [8] Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator?s judgment, to achieve a score of ³70 on an 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. [9] Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol. [10] Patients and parents must be able to communicate effectively with the investigator and site personnel. Are the trial subjects under 18? yes Number of subjects fo
Exclusion criteria
Exclusion criteria: [11] Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis. [12] Patients who weigh less than 20 kg at study entry (Visit 1). If a patient?s weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes. [13] Patients who have a history of bipolar disorder (I or II), psychosis, or pervasive developmental disorder, or comorbid with any mood disorders. If the investigator believes that such a diagnosis has previously been made in error, he/she should contact the 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 are currently taking anticonvulsants for seizure control. [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 multiple adverse drug reactions. [17] 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 that the investigator considers indicative of abuse. [18] Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure. [19] Patients who have a 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 that has sympathomimetic activity. Such medications can be taken on an as-needed basis. [20] Patients who in the investigator?s judgment 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 activity (for example, St. John?s Wort, melatonin). [21] Patients who at any time during the study are likely to begin a structured psychotherapy aimed at ADHD. Psychotherapy initiated at least 1 month prior to study participation is acceptable; however, after study participation has begun only supportive or educational therapy is permitted. [22] Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 2. [23] Patients with history of glaucoma. [24] Patients with hypertension. [25] Female patients who are pregnant or who are breast-feeding. Sexually active females must use a medically acceptable method of contraception. For this study, medically acceptable means of contraception include barrier methods (condom or diaphragm combined with spermicidal agent) or oral contraception. The rhythm method (abstinence during predicted times of ovulation with unprotected intercourse at other times) or coitus interruptus prior to ejaculation by the male partner are not acceptable means of contraception for this study if used in the absence of medically acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: The primary objective of study B4Z-XM-LYDM (LYDM) is to test the hypothesis that efficacy is superior in atomoxetine-treated patients compared to those on placebo, as assessed by ADHDRS?IV?Parent:Inv total score after 12 weeks of treatment among newly diagnosed cases of ADHD outpatients. Efficacy will be measured by comparing the differences in change in ADHDRS?IV?Parent:Inv total score in atomoxetine patients compared with placebo patients at 12 weeks.;Secondary Objective: ·To evaluate the efficacy of atomoxetine compared to placebo, using ADHDRS?IV?Parent:Inv total score after 9, 6 and 4 weeks of treatment, and from week 6 to week 12 of treatment ·To evaluate the efficacy of atomoxetine compared to placebo, using CGI-S-ADHD and CPRS during double blind period. ·To assess long-term efficacy with atomoxetine in the open label period measured by the change from baseline in total score from the ADHDRS?IV?Parent:Inv, CGI-ADHD-S and CPRS-R:S during the open label phase of study. ·To evaluate the efficacy of atomoxetine compared with placebo in increasing quality of life assessed by CHIP for each age group up 12 weeks. ·To assess safety and tolerability among this patient population during double blind and open label phase of study. ·To describe baseline comorbidity among this patient population with Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version;Primary end point(s): The primary objective of study B4Z-XM-LYDM (LYDM) is to test the hypothesis that efficacy is superior in atomoxetine-treated patients compared to those on placebo, as assessed by ADHDRS?IV?Parent:Inv total score after 12 weeks of treatment among newly diagnosed cases of ADHD outpatients. Efficacy will be measured by comparing the differences in change in ADHDRS?IV?Parent:Inv total score in atomoxetine patients compared with placebo patients at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 6.1.2. Secondary Efficacy Measures In addition to the ADHDRS-IV-Parent:Inv subscales and symptom counts, efficacy will also be evaluated through the following secondary measures. 6.1.2.1. Clinical Global Impressions? Attention-Deficit/Hyperactivity Disorder?Severity (CGI-ADHD-S) 6.1.2.3. Conners? Parent Rating Scale-Revised: Short Form (CPRS-R:S);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Spain
Contacts
Public ContactClinical Operations
Lilly S.A.
Outcome results
None listed