Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)

Official Title: “An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder”

The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 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 8 weeks
    Safety Issue?: Yes

Secondary Measures

• Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Change From Endpoint to Baseline in Stroop Color Word Test
  • Time Frame: baseline and 8 weeks
    Safety Issue?: No
• Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
  • Time Frame: over 8 weeks
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
  • Time Frame: over 8 weeks
    Safety Issue?: Yes
• Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
  • Time Frame: over 8 weeks
    Safety Issue?: Yes
• Cytochrome P450 2D6 (CYP2D6) Phenotype Status
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• at least 18 years of age
• meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
• have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater

Exclusion Criteria:

• Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (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.
• 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.
• 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.
• 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 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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00530335

Study ID Number: 11821

ClinicalTrials.gov Identifier: NCT00530335

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

Lilly Clinical Trial Registry