Official Title: “An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-Deficit/Hyperactivity Disorder”

The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • Study drug will be administered once daily in the morning. This study is designed with 4-step titration. At Visit 2, study drug will be started from 40 mg/day, and .be increased to 80 mg/kg on Day 7, 105 mg/kg on Day 14, and 120 mg/day on Day 28. Total administration period would be 8 weeks. The dosage would be adjusted according to investigator's decision based on safety and tolerability

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• The primary objective is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adults patients who meet DSM-IV™ criteria for ADHD
  • Time Frame: 2 months
    Safety Issue?: Yes

Secondary Measures

• To investigate to detect change in symptoms by CAARS:SV
  • Time Frame: 2 months
    Safety Issue?: No
• To assess change in clinical impressions(CGI-ADHD-S), depression (HAMD-17), anxiety (HAMA), executive cognition (Stroop Color Word Test), and functional outcomes (SF-36)
  • Time Frame: 2 months
    Safety Issue?: No

Inclusion Criteria:

• 1. at least 18 years of age
• 2. meet CAADID diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
• 3. have a CGI-ADHD-S score of 4 (moderate symptoms) or greater

Exclusion Criteria:

• 1. Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the HAMD-17 at Visit 1 and Visit 2.
• Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
• 2. Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
• 3. Patients who have any history of bipolar disorder (DSM-IV) , any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
• 4. Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.

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 Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636818

Study ID Number: 12112

ClinicalTrials.gov Identifier: NCT00636818

Health Authority: China: State Food and Drug Administration

Lilly Clinical Trial Registry