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

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2009

Detailed Clinical Trial 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).

Interventions Used in this Clinical Trial

  • Drug: Atomoxetine Hydrochloride
    • Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
  • Drug: Placebo
    • Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Atomoxetine
    • Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
  • Placebo Comparator: Placebo
    • Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • 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
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No

Secondary Measures

  • Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) – Participant
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) – Participant
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) – Spouse/Significant Other
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) – Spouse/Significant Other
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) – Participant
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) – Participant
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) – Spouse/Significant Other
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) – Spouse/Significant Other
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score – Total Stress and Life Stress
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score – Parent Domains
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score – Child Domains
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score – Total Stress and Life Stress
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score – Parent Domains
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score – Child Domains
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
    • Time Frame: Baseline, 12 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
    • Time Frame: Baseline, 12 Weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
    • Time Frame: Baseline, 24 Weeks
      Safety Issue?: No
  • Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • 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
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale
    • Time Frame: Baseline, 8 weeks
      Safety Issue?: No
  • Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale
    • Time Frame: Baseline, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)
    • Time Frame: Baseline, 8 weeks, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)
    • Time Frame: Baseline 12 weeks, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
    • Time Frame: Baseline, 1 week
      Safety Issue?: No
  • Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
    • Time Frame: Baseline, 2 weeks
      Safety Issue?: No
  • 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
    • Time Frame: Baseline, after 2-week titration period beginning at Week 24
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(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, Eli Lilly and Company

Citations Reporting on Results

Young JL, Sarkis E, Qiao M, Wietecha L. Once-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol. 2011 Mar-Apr;34(2):51-60. doi: 10.1097/WNF.0b013e31820c00eb.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00190775