An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-deficit/Hyperactivity Disorder

Eli Lilly and Company1 site in 1 country45 target enrollmentMarch 2008

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: Discontinuations Due to Adverse Events (AE)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

October 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

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 Impressions-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 17-item Hamilton Depression Rating Scale (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

Discontinuations Due to Adverse Events (AE)

Time Frame: Baseline to 8 Weeks

The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.

Secondary Outcomes

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(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in Stroop Color Word Test(Baseline and 8 Weeks)
Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)(Baseline and 8 Weeks)
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study(Baseline to 8 Weeks)
Significant Changes in Body Weight During the Study(Baseline to 8 Weeks)
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion(Baseline to 8 Weeks)
Cytochrome P450 2D6 (CYP2D6) Phenotype Status(8 Weeks)