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Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder

NCT ID: NCT00962104

Last Updated: 2012-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to assess the efficacy, the quality of life, and the safety of multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity disorder (ADHD).

Detailed Description

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The treatment will be initiated at the lowest dosage 40 milligrams per day (mg/day), and it will be titrated up to 80 mg/day. Patients who are unable to tolerate a dose of at least 80 mg/day through the end of this study will be discontinued. The dosage will be titrated up to a maximum of 120 mg/day.

Conditions

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Attention Deficit Hyperactivity Disorder

Keywords

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atomoxetine

Group Type EXPERIMENTAL

Atomoxetine

Intervention Type DRUG

40-120 milligrams (mg) taken by mouth, once daily for 10 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Taken by mouth, once daily for 10 weeks.

Interventions

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Atomoxetine

40-120 milligrams (mg) taken by mouth, once daily for 10 weeks.

Intervention Type DRUG

Placebo

Taken by mouth, once daily for 10 weeks.

Intervention Type DRUG

Other Intervention Names

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LY139603

Eligibility Criteria

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Inclusion Criteria

* Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current attention deficit/hyperactivity disorder (ADHD) as well as criteria for a historical diagnosis of ADHD during childhood, both assessed by the Conners' Adult Attention-Deficit/Hyperactivity Disorder Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition at screening
* Patients must have a score of 2 or greater on at least 6 items of either the inattentive or hyperactive/impulsive core subscales at randomization or screening on the rated Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-item total ADHD symptom score. In addition, their total score on the 18-item total ADHD symptom score must be 20 or greater.
* Patients must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity score of 4 (moderate symptoms) or greater.
* Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, 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 must be able to swallow capsules.

Exclusion Criteria

* Patients who meet full DSM-IV-TR diagnostic criteria for any history of bipolar disorder or any history of schizophrenia and other psychotic disorders, or patients who had received injectable sustained-release neuroleptics.
* Patients with depressive disorder who also have a total score of 12 or greater on the Hamilton Depression Rating Scale-17 items at randomization. Patients who have both a current or past history of major depression and received any anti-depression drug therapy within 6 months of screening.
* Patients who meet DSM-IV-TR diagnostic criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy, except for those taking benzodiazepine analogs for anxiety, which need to be limited.
* Patients who have been diagnosed (DSM-IV-TR) with a pervasive developmental disorder.
* 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 who have received atomoxetine in a prior clinical study.
* Patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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

Site Status

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Fukushima, , Japan

Site Status

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Hokkaido, , Japan

Site Status

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Hyōgo, , Japan

Site Status

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Kanagawa, , Japan

Site Status

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Kumamoto, , Japan

Site Status

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Kyoto, , Japan

Site Status

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Nara, , Japan

Site Status

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Osaka, , Japan

Site Status

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Saitama, , Japan

Site Status

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Tokyo, , Japan

Site Status

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Bucheon-si, , South Korea

Site Status

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Gwangjin-Gu, , South Korea

Site Status

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Jeonju, , South Korea

Site Status

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, , South Korea

Site Status

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Sungnam-Si, , South Korea

Site Status

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Yangsan, , South Korea

Site Status

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Keelung, , Taiwan

Site Status

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Neihu Taipei, , Taiwan

Site Status

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Niao Sung Hsiang, , Taiwan

Site Status

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Taichung, , Taiwan

Site Status

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

Site Status

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.

Taoyuan District, , Taiwan

Site Status

Countries

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China Japan South Korea Taiwan

References

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Westfall PH, Krishen A. Optimally weighted, fixed sequence and gatekeeping multiple testing procedures. J Stat Plan Inference. 2001;99:25-40.

Reference Type BACKGROUND

HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

Reference Type BACKGROUND
PMID: 13638508 (View on PubMed)

Riskind JH, Beck AT, Brown G, Steer RA. Taking the measure of anxiety and depression. Validity of the reconstructed Hamilton scales. J Nerv Ment Dis. 1987 Aug;175(8):474-9. doi: 10.1097/00005053-198708000-00005.

Reference Type BACKGROUND
PMID: 3625186 (View on PubMed)

Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.

Reference Type DERIVED
PMID: 25019647 (View on PubMed)

Other Identifiers

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B4Z-JE-LYEE

Identifier Type: OTHER

Identifier Source: secondary_id

12107

Identifier Type: -

Identifier Source: org_study_id