Atomoxetine Phase 2 Study in Japanese Adult Patients With ADHD - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00530335

Purpose

The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet DSM-IV criteria for ADHD

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

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Factorial Assignment, Safety Study
Official Title:	An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Discontinuation rate due to adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Connors's Adult ADHD Rating scale-Investigator rated: Screening version - Japanese version (CAARS-Inv:SV-J) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Connors's Adult ADHD Rating scale-ISelf Report: Screening version - Japanese version (CAARS-S:SV-J) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-ADHD - Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hamilton Depression Rating scale - 17 items (HAMD-17) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hamilton Anxiety Rating Scale - 14 items (HAMA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
SF36 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Stroop Color Word Test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Clinical laboratory Tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Body Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
ECGs [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
CYP2D6 status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	September 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Atomoxetine 40 mg/day QD PO for 1 week; 80 mg/day QD PO for 1 week, 105 mg/day QD PO for 2 weeks, 120 mg/day QD PO for 4 weesk

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-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: NCT00530335

Locations

Japan
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.
Hyogo, Japan, 661-0002
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.
Fukushima, Japan, 960-1295
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.
Chiba, Japan, 272-8516
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.
Saitama, Japan, 350-0495
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.
Kanagawa, Japan, 259-1193
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.
Kyoto, Japan, 606-8507
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.
Tokyo, Japan, 160-0023
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.
Nara, Japan, 634-8522
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.
Kumamoto, Japan, 862-0920
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.
Aichi, Japan, 466-8560
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.
Hokkaido, Japan, 060-8648
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.
Ishikawa, Japan, 920-8641

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11821, B4Z-JE-LYED
Study First Received:	September 14, 2007
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00530335
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Signs and Symptoms
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
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009