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

Eli Lilly and Company1 site in 1 country211 target enrollmentNovember 2009

InterventionsAtomoxetine

Overview

Phase: Phase 3
Intervention: Atomoxetine
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Enrollment: 211
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events Leading to Discontinuation
Status: Completed
Last Updated: 13 years ago

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

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

January 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Patients who have completed the B4Z-JE-LYEE study (NCT00962104) and signed the Informed Consent Document (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.

•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 milligrams/day (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.

Intervention: Atomoxetine

Number of Participants With Adverse Events Leading to Discontinuation

Time Frame: Baseline through 48 weeks

Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)(Baseline, 48 weeks)
Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores(Baseline, 48 weeks)
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 )(Baseline, 48 weeks)
Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items(Baseline, 48 weeks)
Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)(Baseline, 48 weeks)
Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)(Baseline, 48 weeks)
Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items(Baseline, 48 weeks)