Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)

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).

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine

Primary Measures

• Discontinuations Due to Adverse Events (AE)
  • Time Frame: Baseline to 8 Weeks
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Stroop Color Word Test
  • Time Frame: Baseline and 8 Weeks
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)
  • 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: Baseline to 8 Weeks
    Safety Issue?: Yes
• Significant Changes in Body Weight During the Study
  • Time Frame: Baseline to 8 Weeks
    Safety Issue?: Yes
• Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
  • Time Frame: Baseline to 8 Weeks
    Safety Issue?: Yes
• Cytochrome P450 2D6 (CYP2D6) Phenotype Status
  • Time Frame: 8 Weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. at least 18 years of age
• 2. 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
• 3. have a Clinical Global Impressions-ADHD-Severity (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 17-item Hamilton Depression
• Rating Scale (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 Investigator: Eli Lilly and Company Industry

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 February 09, 2012

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