Atomoxetine Asian Study in Adult Subjects With ADHD - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00636818

Purpose

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).

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine	Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-Deficit/Hyperactivity Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The primary objective 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 adults patients who meet DSM-IV™ criteria for ADHD [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate to detect change in symptoms by CAARS:SV [ Time Frame: 2 months ] [ Designated as safety issue: No ]
To assess change in clinical impressions(CGI-ADHD-S), depression (HAMD-17), anxiety (HAMA), executive cognition (Stroop Color Word Test), and functional outcomes (SF-36) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	March 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Atomoxetine Study drug will be administered once daily in the morning. This study is designed with 4-step titration. At Visit 2, study drug will be started from 40 mg/day, and .be increased to 80 mg/kg on Day 7, 105 mg/kg on Day 14, and 120 mg/day on Day 28. Total administration period would be 8 weeks. The dosage would be adjusted according to investigator's decision based on safety and tolerability

Arms

Assigned Interventions

A: Experimental

Drug: Atomoxetine

Study drug will be administered once daily in the morning. This study is designed with 4-step titration. At Visit 2, study drug will be started from 40 mg/day, and .be increased to 80 mg/kg on Day 7, 105 mg/kg on Day 14, and 120 mg/day on Day 28. Total administration period would be 8 weeks. The dosage would be adjusted according to investigator's decision based on safety and tolerability

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

at least 18 years of age
meet CAADID diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
have a 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636818

Locations

China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, China, 100088
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changsha, China, 410011
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guang Zhou, China, 560370
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Busan, Korea, Republic of, 602739
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
In Cheon, Korea, Republic of, 405-760
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jeon Ju-City, Korea, Republic of, 561-712
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, Korea, Republic of, 120-752
Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neihu Taipei, Taiwan, 114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Niao Sung Hsiang, Taiwan, 833
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taipei, Taiwan, 100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tao-Yuan, Taiwan, 333

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12112, B4Z-JE-LYEH
Study First Received:	March 7, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00636818 History of Changes
Health Authority:	China: State Food and Drug Administration; Korea: Food and Drug Administration; Taiwan: Department of Health

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Adrenergic Agents
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Atomoxetine

Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 07, 2009