Attention Deficit Hyperactivity Disorder MedDRA version: 9.1 Level: LLT Classification code 10003736 Term: Attention deficit/hyperactivity disorder
Conditions
Interventions
Trade Name: Strattera
Product Name: Atomoxetine Hydrochloride
Product Code: LY139603
Pharmaceutical Form: Capsule, hard
Sponsors
Eli Lilly Nederland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: (1) Patients must be male and female patients who are at least 13 years of age and not more than 17 years of age when the informed consent document is obtained. (2) Patients must have a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision© (DSM-IV-TR©) criteria for ADHD. For the purpose of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL). (3) At Visit 1 and 2 patients must score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version (See Protocol Attachment LYEL.5). In addition, they must have a CGI-ADHD-S score ?4 at both Visit 1 and Visit 2 (4) Patients must meet DSM-IV-TR© criteria for cannabis abuse or dependence and use cannabis at minimum of 5 joints per week during the last month before enrollment. Current abstinence is allowed the week before enrollment. (5) 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 ?80 on an IQ test). (6) Patients and parents (legal representative) have been judged by the investigator to be reliable to keep appointments for clinic visits, all tests and examinations required by the protocol. (7) This Inclusion criterion applies to all females. Test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control if they are sexually active (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 week following the last dose of study drug]. (8) Patients must be able to swallow capsules (study drug). 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
Exclusion criteria: (9) Patients who weigh less than 20 kg at Visit 1. (10) Patients with a history of Bipolar I or II disorder, schizophrenia, another psychotic disorder. (11) Patients who have a significant medical condition such as heart disease, prolonged QT interval, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests. Patients who have taken (or are currently taking) anticonvulsants for seizure control. (12) Patients determined by the investigator to be at serious suicidal risk. This evaluation must include the items a, b, c, d and e of K-SADS-PL’s depression module, and there can not be a score of 3 in any of these items. (13) Patients with a history of alcohol or drug (other than cannabis) abuse within the past 3 months (excessive or compulsive use as judged by the investigator), or who are currently using alcohol in a manner which the investigator considers indicative of abuse or any drugs of abuse (other than cannabis), or any prescribed or over-the-counter medication in a manner which the investigtor considers indicative of abuse. (14) Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions. (15) Patients who, prior to this study, did not respond to or did not tolerate atomoxetine. (16) Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure. (17) Patients who have a medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumour), or who are taking a medication on a daily basis, (for example, albuterol, inhalation aerosols, pseudoephedrine) that has sympathomimetic activity are excluded. (18) Patients who in the investigator’s judgment are likely to need psychotropic medications apart from the drug under study, including health-food supplements that in the investigator’s opinion have central nervous system activity (for example, St.John’s Wort, melatonin). (19) Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks (14 days) prior to Visit 2. (20) Patients with Narrow Angle (angle-Closure) Glaucoma (21) 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 (22) Female patients with a positive Beta HCG pregnancy test or have recently given birth are not eligible to participate. (23) Patients who at any time during Study Period II are likely to begin a structured psychotherapy. Psychotherapy initiated at least 2 months prior to study participation is acceptable General psychoeducation is allowed at any time and recommended.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that atomoxetine given at a dose of 1.2 mg/kg/day (once daily) for 12 weeks reduces symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) versus baseline in outpatients aged 13 through 17 years with a diagnosis of ADHD and comorbid cannabis abuse. ADHD symptoms are measured by ADHD Rating Scale-IV-Parent Version:investigator scored (ADHD-RS).;Secondary Objective: •To assess whether atomoxetine reduces symptoms of ADHD as measured by Clinical Global Impression-ADHD-Improvement and Global Impression of Perceived Difficulties versus baseline. •To assess the safety and tolerability of atomoxetine in this population. •To assess the change from baseline of anxiety symptoms as measured by Pediatric Anxiety Rating Scale. •To assess the change from baseline of depressive symptoms as measured by Children’s Depression Rating Scale-Revised. •To assess neurocognitive performance as measured by a test battery (Stop-Signal Task, Timetest, Reinforcement Contingency Test). •To assess the change from baseline of self-rated symptoms of cannabis craving as measured by a Marijuana Craving Questionnaire. •To explore the cannabis consumption in patients using atomoxetine based on a Timeline Followback Calendar. •To explore addiction potential of atomoxetine based on a Visual Analog Scale.;Primary end point(s): The primary objective of this study is to analyse the reduction of symptoms of ADHD versus baseline in outpatients aged 13 through 17 years with a diagnosis of ADHD and comorbid cannabis abuse when Atomoxetine is given at a dose up to 1.2 mg/kg/day (once daily) for 12 weeks. ADHD symptoms are measured by ADHD Rating Scale-IV-Parent Version:investigator score (ADHD-RS). | — |
Countries
Netherlands
Outcome results
None listed