An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder

Eli Lilly and Company1 site in 1 country45 target enrollmentSeptember 2007

ConditionsAttention Deficit Hyperactivity Disorder

InterventionsAtomoxetine

DrugsAtomoxetine

Overview

Phase: Phase 2
Intervention: Atomoxetine
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 45
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events Leading to Discontinuation
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

April 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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
•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
•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.

Arms & Interventions

Atomoxetine

Intervention: Atomoxetine

Outcomes

Primary Outcomes

Number of Participants With Adverse Events Leading to Discontinuation

Time Frame: over 8 weeks

Secondary Outcomes

Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)(baseline and 8 weeks)
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)(baseline and 8 weeks)
Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity(baseline and 8 weeks)
Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score(baseline and 8 weeks)
Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score(baseline and 8 weeks)
Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores(baseline and 8 weeks)
Change From Endpoint to Baseline in Stroop Color Word Test(baseline and 8 weeks)
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study(over 8 weeks)
Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study(over 8 weeks)
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion(over 8 weeks)
Cytochrome P450 2D6 (CYP2D6) Phenotype Status(8 weeks)