A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder

Official Title: “Long-Term, Open-Label Safety and Efficacy Study of Atomoxetine Hydrochloride in Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)”

The purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • 40-120 mg/day taken by mouth, once a day for 48 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine

Primary Measures

• Number of participants with adverse events leading to discontinuation
  • Time Frame: Over 48 weeks
    Safety Issue?: Yes

Secondary Measures

• Mean change from baseline to 48 weeks endpoint in the by Conners' Adult ADHD Rating Scale- Investigator Rated: Screening Version 18-item total ADHD symptom score (CAARS-InvSV)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in the by the Adult ADHD Quality of Life Measure (AAQoL)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in comorbid, anxiety symptoms, as measured by Hamilton Anxiety Rating Scale-14 items (HAMA-14)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in the BRIEF-A Version: Informant scores (BRIEF-A:Informant scores)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No
• Mean change from baseline to 48 weeks endpoint in comorbid, depressive symptoms, as measured by Hamilton Depression Rating Scale-17 items (HAMD-17)
  • Time Frame: Baseline and 48 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients who have completed the B4Z-JE-LYEE study and signed the ICD.
• Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, 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.

Exclusion Criteria:

• Patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
• Edition, Text Revision criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy within previous study except for those taking benzodiazepines analogs for anxiety. The dosage of diazepam equivalents should not be more than 5 mg/day.
• 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 with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine or require treatment with excluded medications.
• 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/NCT00969618

Study ID Number: 12397

ClinicalTrials.gov Identifier: NCT00969618

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