Attention-Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder that has its onset in childhood, and that is estimated to occur in 3% to 6% of school-age children. ADHD is characterized by levels of increased motor activity, impulsiveness, distractibility, restlessness and inattention that is maldaptive and inconsistent with the child´s developmental level.
Conditions
Interventions
Trade Name: Strattera
Product Name: atomoxetine
Product Code: LY139603
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Eli Lilly Sweden AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1] Meet the criteria for ADHD of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IVä) as well as severity criteria. Diagnosis is assessed by the investigator’s clinical evaluation as well as administration of the K-SADS-PL structured interview (Kaufman et al. 1997; see Section 3.1 Study Period I, and Attachment LY15.1, Schedule of Events). [2] Meet a symptom severity threshold of 1.5 standard deviations above age and sex norms for their diagnostic subtype on the ADHDRS-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) (Attachment LY15.7). This severity threshold must be met at Visit 1 and maintained at Visit 2. [3] Be at least 7 years of age, but not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained. [4] For female subjects of child-bearing potential only, 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 (for example, oral contraceptives, levonorgestrel implant, or 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. [5] Be able to swallow capsules. [6] 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 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. [7] For patients and parents/legal guardians, be judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol. [8] For patients and parents, be able to communicate effectively with the investigator and site personnel. 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] 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. [10] Have a documented history of Bipolar Disorder or any history of psychosis or pervasive development disorder (autistic spectrum disorder). [11] Are pregnant or breastfeeding. [12] Have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are taking) anticonvulsants for seizure control are not eligible to participate. [13] Are at serious suicidal risk as assessed by the investigator. [14] Are taking any psychotropic medication on a regular basis, including health-food supplements that the investigator feels may have central nervous system activity (for example, St. John’s Wort, Ephedra, melatonin, Omega-3), must have a washout equal to a minimum of 5 half-lives of that medication prior to starting atomoxetine treatment. If the half-life of a medication is unknown, the Lilly clinical research physician should be consulted prior to entering the patient into the study. [15] Have been treated previously for ADHD with psychostimulants such as Methylphenidate or Ritalin. [16] Have 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 the investigator considers indicative of abuse. [17] Have significant prior or current medical conditions (for example, human immunodeficiency virus [HIV], surgically corrected congenital heart defects, or malignancy). [18] Have any medical condition that would markedly increase sympathetic nervous system activity (for example, catecholamine-secreting neural tumour). [19] Have a thyroid-stimulating hormone (TSH) level consistent with hyperthyroidism or hypothyroidism will be excluded. However, patients previously diagnosed with hyperthyroidism or hypothyroidism, who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid will be allowed to participate in the study. [20] Have acute closed-angle glaucoma. [21] Are taking a medication that has sympathomimetic activity (e.g., albuterol, inhalation aerosols, pseudoephedrine). However, such medications can be taken on an as-needed basis. [22] Use monoamine oxidase inhibitors (MAOIs) during the 2 weeks (14 days) prior to Visit 2. [23] Have current or past history of hypertension. For the purposes of this protocol, hypertension is 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 in Wilton (1983). The adequacy of historical diagnoses will be determined by the investigator. [24] Are receiving formal structured individual or family psychotherapy during Study Period I and Study Period II. Patients may enter the study if such treatment has been completed before entry into the trial. Formal structured individual or family therapy is allowed during Study Period III. [25] Have a poor understanding of the Swedish language that in the opinion of the investigator renders the application of rating scales inappropriate. [26] Are, in the opinion of the investigator, unsuitable in any other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to test the hypothesis that atomoxetine and psychoeducation given for 10 weeks is superior to placebo and psychoeducation in improving overall functioning of patients, age 7-15 years, with Attention-Deficit/Hyperactivity Disorder (ADHD), as measured by the mean change in the total score of the Child Health and Illness Profile-Child Edition-Parent form (CHIP-CE-Parent form) domain Achievement (containing two subdomains: Academic performance och Peer relations).;Secondary Objective: Secondary aims with the study is to compare atomoxetine and psychoeducation with placebo and psychoeducation at 10 weeks of double-blind treatment, measured with the remaining four CHIP-CE domains (Satisfaction, Comfort, Risk Avoidance, Resilience); total CHIP-CE score; "Jag tycker jag är" (I think I am), a Swedish self-assessment scale regarding self image, Family Burden of Illness (FBIM), a simple questionnaire on the impact of the child's illness on family life and functioning; and Appraisal of Stress in Family Rearing (ASCR), a questionnaire regarding the degree of emotional stress that parents' experience in their rearing of their child. In a separate health outcomes section the direct and indirect costs for the family and for the society will be explored, before and after treatment. ;Primary end point(s): The primary efficacy variable is the mean score on the Achievement domain of the CHIP-CE. The primary efficacy analysis will be a repeated measures mixed model analysis. The dependent variable will be evaluated at Visits 2 and 7. The model will contain terms for baseline score, treatment, site, visit, and treatment-by-visit interaction. Baseline is defined as scores obtained at Visit 2. The analysis will include CDRS-R as a covariate, since earlier findings have reported possible improvement of the CDRS-R score as a result of the treatment, which potentially may influence the primary efficacy variable. | — |
Countries
Sweden
Outcome results
None listed