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A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Atomoxetine Hydrochloride (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.

Clinical Details

Official title: A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score

Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score

Secondary outcome:

Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant

Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant

Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other

Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other

Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant

Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant

Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other

Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other

Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress

Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains

Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains

Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress

Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains

Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains

Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form

Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form

Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form

Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form

Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form

Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags

Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale

Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale

Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores

Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)

Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)

Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)

Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores

Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo

Detailed description: The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text

Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID).

- Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or

greater Visit 2 and 3.

- Adult Men and Women age 18 years or older at time informed consent is obtained.

- Must be in a reciprocal relationship with a person of the opposite sex living in same

defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.

- Must have one or more children 6-17 years of age living the home as the primary

residence. Exclusion Criteria:

- Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition

(DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder.

- Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current

anxiety disorder.

- Taking psychotropic medications on a regular basis.

- Having any medical condition that would be exacerbated or not appropriate for

inclusion in this trial.

- Previously taken an adequate trial of atomoxetine.

Locations and Contacts

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., Santurce 00912, Puerto Rico

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., Irvine, California 92618, United States

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., Gainesville, Florida 32607, United States

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., Tampa, Florida 33606, United States

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., Atlanta, Georgia 30328, United States

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., Libertyville, Illinois 60048, United States

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., Indianapolis, Indiana 46202, United States

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., Bardstown, Kentucky 40004, United States

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., Baltimore, Maryland 21208, United States

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., Rochester Hills, Michigan 48307, United States

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., Troy, Michigan 48085, United States

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., Mount Kisco, New York 10549, United States

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., Chapel Hill, North Carolina 27514, United States

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., Cleveland, Ohio 44106, United States

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., Toledo, Ohio 43623, United States

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., Media, Pennsylvania 19063, United States

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., Houston, Texas 77090, United States

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., Salt Lake City, Utah 84132, United States

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., Herndon, Virginia 20170, United States

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., Middleton, Wisconsin 53562, United States

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., West Allis, Wisconsin 53227, United States

Additional Information

Starting date: September 2004
Last updated: August 18, 2011

Page last updated: August 23, 2015

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