Attention-Deficit/Hyperactivity Disorder (ADHD) MedDRA version: 9.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder
Conditions
Interventions
Trade Name: Strattera
Product Name: Atomoxetine hydrochloride
Product Code: LY139603
Pharmaceutical Form: Capsule, hard
CAS Number: 8224
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients must be male or female outpatients who are at least 18 years of age and no more than 50 years of age when informed consent is obtained. [2] Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria for current ADHD as well as meet criteria for a historical diagnosis of ADHD during childhood as assessed by the Conners’ Adult ADHD Diagnostic Interview for DSM-IV (CAADID). Corroboration for key symptom domains being present during childhood should be obtained through a third-party source of information. A third-party source of information could include, for example, interviewing (by phone or in person) the patient’s spouse, partner, family member, or close friend who can attest that key ADHD symptoms were present during childhood; medical records that establish childhood diagnosis of ADHD; or school records that reference symptoms of key ADHD domains. [3] Patients must have a score of =2 on at least 6 items of either the inattentive or hyperactive core subscales at Visit 1 on the rated CAARS-Inv:SV. In addition, their CAARS-Inv:SV 18-item total ADHD symptom score (the sum of the inattention and hyperactivity/impulsivity subscales) must be =20. [4] Patients must have a score of =2 on at least 6 items of either the inattentive or hyperactive core subscales of the CAARS-O:SV for current symptoms (typically as rated by a spouse, partner, parents or other family members, or by a close friend who can provide reliable and trustworthy information). Results need not be obtained in person, provided the observer’s identity and relationship to the patient is documented (the patient can bring the scale to the observer outside of the clinic, or ratings can be obtained by telephone). Observer ratings must be available prior to completing Visit 2. [5] Patients must have a CGI-ADHD-S score of =4 (moderate symptoms) at Visit 1 and Visit 2. [6] Patients must have laboratory results, including serum chemistries, hematology, and urinalysis, that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation), and there is 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 Eli Lilly and Company (Lilly) clinical research physician monitoring the study should be consulted. [7] Patients must have an electrocardiogram (ECG) performed at Visit 1 or between Visit 1 and Visit 2. The results of the screening ECG must be read, and the results must be available to the investigator or qualified designee, prior to dispensing atomoxetine at Visit 2. If an ECG shows an abnormality, the Algorithm for Assessing Electrocardiogram Abnormalities (Protocol Attachment LYDO.3) for including or excluding the patient should be followed. Patients with other abnormalities may be included at the discretion of the investigator; however, the Lilly physician monitor or designee must
Exclusion criteria
Exclusion criteria: [12] Patients who meet full DSM-IV-TR diagnostic criteria for any history of bipolar disorder, current major depression, a current anxiety disorder (including generalized anxiety disorder, panic disorder, or social phobia), or any history of a psychotic disorder (confirmed by the structured interview). Assessment will be by clinical history and a Structured Clinical Interview for DSM-IV Axis I disorders (SCID). If the investigator believes that such a diagnosis has previously been made in error, he/she should contact the sponsor and discuss the case history with the Lilly physician responsible for the study prior to allowing the patient to enter the study. [13] Patients with clinically significant depression or anxiety, as measured by HAMD 17 or HAMA scores =15 at Visit 2. [14] Patients with organic brain disease; for example, dementia, traumatic brain injury residual, or a history of any seizure disorder (except febrile seizures during childhood). In addition, patients taking anticonvulsants for seizure control currently or at any time in the past. [15] Patients with hyperthyroidism or hypothyroidism. Patients who were previously diagnosed with hyperthyroidism or hypothyroidism who are clinically and chemically euthyroid and whose dose of thyroid supplement has been stable for at least the past 3 months (and who are expected to be euthyroid for the trial duration) are allowed to participate in the study. In some cases, investigators may require regular thyroid followup, as clinically indicated. [16] Patients who, in the opinion of the investigator, are at serious suicidal or homicidal risk. [17] Patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions. [18] Patients who have a known history of glaucoma. [19] Male patients with a history of difficulty starting a stream of urine or other symptoms suggestive of prostate enlargement, or other evidence of urinary hesitancy on clinical history. [20] Female patients who are pregnant or nursing. [21]Patients taking psychotropic medications, including health food supplements judged by the investigator to be likely to have central nervous system activity (for example, St John’s Wort, gingko leaf, melatonin). If the patient is taking the medication prior to study entry, there must be a washout period equal to a minimum of 5 half-lives of that medication prior to Visit 2. If the half-life of a medication is unknown (for example, herbal products), then the patient should have a 28-day medication washout. [22] Patients 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 chronic abuse or who meet DSM IV-TR criteria for alcohol or other substance dependence. [23] Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine (for example, cardiovascular disease that would be aggravated by increased pulse or blood pressure), or require treatment with excluded medications. [24] Patients who have any medical condition (for example, catecholamine-secreting neural tumor) that has sympathomimetic activity, or who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy measure is the proportion of patients maintaining a response at the end (Visit 18) of the double-blind treatment phase. Any patient who discontinues during the double-blind post-randomization period will be treated as a non-responder for this analysis. More detail of the definition of response will be described in the statistical analysis plan and the ERB supplement. The treatment comparison of proportions will be tested using Fisher’s exact test. ; Secondary Objective: Secondary Gatekeeper Objectives: • To assess the maintenance of efficacy of atomoxetine compared with placebo during double-blind treatment, as measured by the number of days until relapse. • to assess the quality of life in patients treated with atomoxetine compared with placebo during double-blind treatment, as measured by the mean change from baseline using the AAQoL scores at the last visit of the double-blind period. Additional Secondary Objectives: Please see protocol ;Main Objective: The primary objective of Study LYDO is to test the hypothesis that atomoxetine is superior to placebo in maintaining a satisfactory response at the end of double-blind treatment in adult outpatients with ADHD who show a satisfactory response to acute atomoxetine treatment, as measured by the proportion of patients who meet predefined response criteria.These criteria are specified in an ethical review board (ERB) supplement to the protocol to which the investigator must remain unblinded. | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed