NCT00510276

Brief Summary

This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 3, 2010

Completed
Last Updated

April 14, 2010

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

July 30, 2007

Results QC Date

January 27, 2010

Last Update Submit

April 7, 2010

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint

    CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.

    Baseline, Week 12

Secondary Outcomes (38)

  • Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score

    Baseline, 12 weeks

  • Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale

    Baseline, 12 weeks

  • Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale

    Baseline, 12 weeks

  • Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale

    Baseline, 12 weeks

  • Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale

    Baseline, 12 weeks

  • +33 more secondary outcomes

Study Arms (2)

Atomoxetine

EXPERIMENTAL
Drug: Atomoxetine hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Atomoxetine hydrochlorideDRUG

20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks

Also known as: LY139603, Strattera
Atomoxetine
PlaceboDRUG

twice a day, by mouth for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity
  • male or female 18 to 30 years of age
  • must be able to swallow capsules
  • must be able to communicate effectively in English
  • must not have cognitive impairment
  • be reliable to keep appointments for clinic visits and all related tests

You may not qualify if:

  • patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
  • females who are pregnant or breastfeeding
  • patients with dementia or traumatic brain injury
  • patients with a history of severe allergy to atomoxetine
  • have untreated hypertension or thyroid problem
  • have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

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.

Los Angeles, California, 90024, United States

Location

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.

Rolling Hills Est., California, 90274, United States

Location

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.

Spring Valley, California, 91978, United States

Location

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Wildomar, California, 92595, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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South Miami, Florida, 33143, United States

Location

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St. Petersburg, Florida, 33709, United States

Location

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.

Eagle, Idaho, 83616, United States

Location

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.

Topeka, Kansas, 66606, United States

Location

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Lexington, Kentucky, 40509, United States

Location

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Belmont, Massachusetts, 02478, United States

Location

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Farmington Hills, Michigan, 48336, United States

Location

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Omaha, Nebraska, 68198, United States

Location

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.

Las Vegas, Nevada, 89128, United States

Location

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Piscataway, New Jersey, 08854, United States

Location

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.

New York, New York, 10010, United States

Location

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.

Charlotte, North Carolina, 28211, United States

Location

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.

Beachwood, Ohio, 44122, United States

Location

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Cincinnati, Ohio, 45267, United States

Location

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Oklahoma City, Oklahoma, 73103, United States

Location

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.

Charleston, South Carolina, 29405, United States

Location

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.

Burlington, Vermont, 05401, United States

Location

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.

Woodstock, Vermont, 05091, United States

Location

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.

Midlothian, Virginia, 23112, United States

Location

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.

Seattle, Washington, 98104, United States

Location

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Spokane, Washington, 99202, United States

Location

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.

Hato Rey, 00918, Puerto Rico

Location

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.

San Juan, 00907, Puerto Rico

Location

Related Publications (3)

  • Adler LA, Clemow DB, Williams DW, Durell TM. Atomoxetine effects on executive function as measured by the BRIEF--a in young adults with ADHD: a randomized, double-blind, placebo-controlled study. PLoS One. 2014 Aug 22;9(8):e104175. doi: 10.1371/journal.pone.0104175. eCollection 2014.

    PMID: 25148243DERIVED

  • 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.

    PMID: 25019647DERIVED

  • Durell TM, Adler LA, Williams DW, Deldar A, McGough JJ, Glaser PE, Rubin RL, Pigott TA, Sarkis EH, Fox BK. Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial. J Clin Psychopharmacol. 2013 Feb;33(1):45-54. doi: 10.1097/JCP.0b013e31827d8a23.

    PMID: 23277268DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 14, 2010

Results First Posted

March 3, 2010

Record last verified: 2010-04

Locations

US(27)PR(2)