Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder

Official Title: “A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)”

The purpose of this study is to assess the efficacy, the quality of life, and the safety of multiple dosing Atomoxetine in asian adult subjects with ADHD.

The treatment will be initiated at the lowest dosage 40 mg/day, and it will be titrated up to 80 mg/day. Patients who are unable to tolerate a dose of at least 80 mg/day through the end of this study will be discontinued. The dosage will be titrated up to a maximum of 120 mg/day.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • 40-120 mg taken by mouth once daily for 10 weeks.
• Drug: Placebo
  • Taken by mouth once daily for 10 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine
• Placebo Comparator: Placebo

Primary Measures

• Mean change from baseline to 10 weeks endpoint in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version 18-item total ADHD symptom score.
  • Time Frame: Baseline and 10 weeks
    Safety Issue?: No

Secondary Measures

• Mean change from baseline to 10 weeks endpoint in the Adult ADHD Quality Of Life scores.
  • Time Frame: Baseline and 10 weeks
    Safety Issue?: No
• Mean change from baseline to 10 weeks endpoint in the European Quality Of Life: 5 Dimensions Questionnaire scores.
  • Time Frame: Baseline and 10 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
• Edition, Text Revision criteria for current ADHD as well as criteria for a historical diagnosis of ADHD during childhood, both assessed by the Conners' Adult
• Attention-Deficit/Hyperactivity Disorder Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition at screening
• Patients must have a score of 2 or greater on at least 6 items of either the inattentive or hyperactive/impulsive core subscales at randomization or screening on the rated Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self
• Report: Screening Version 18-item total ADHD symptom score. In addition, their total score on the 18-item total ADHD symptom score must be 20 or greater.
• Patients must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity score of 4 (moderate symptoms) or greater.
• Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, required by the protocol.
• Patients must possess an educational level and degree of understanding of the language of their country that enables them to communicate suitably with the investigator and study coordinator.
• Patients must be able to swallow capsules.

Exclusion Criteria:

• Patients who meet full DSM-IV-TR diagnostic criteria for any history of bipolar disorder or any history of schizophrenia and other psychotic disorders, or patients who had received injectable sustained-release neuroleptics.
• Patients with depressive disorder who also have a total score of 12 or greater on the Hamilton Depression Rating Scale-17 items at randomization. Patients who have both a current or past history of major depression and received any anti-depression drug therapy within 6 months of screening.
• Patients who meet DSM-IV-TR diagnostic criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy, except for those taking benzodiazepine analogs for anxiety, which need to be limited.
• Patients who have been diagnosed (DSM-IV-TR) with a pervasive developmental disorder.
• Patients who, in the opinion of the investigator, are at serious suicidal risk or serious risk of harming others, or whose score for Item 11 on the Hamilton Depression
• Rating Scale-17 items is equal or more than 2 at randomization or screening.
• Patients who have received atomoxetine in a prior clinical study.
• Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine.
• Patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions.
• Patients who have received treatment within the past 30 days with a drug that has not received regulatory approval for any indication at the time the informed consent document is obtained.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00962104

Study ID Number: 12107

ClinicalTrials.gov Identifier: NCT00962104

Health Authority: Japan: Ministry of Health, Labor and Welfare