Clinical Trial: A Study in Pediatric Participants With Generalized Anxiety Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Brief Summary: The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome: Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist [ Time Frame: Baseline, 10 weeks ]

PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.


Original Primary Outcome: Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist [ Time Frame: Baseline, 10 weeks ]

Current Secondary Outcome:

  • Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD [ Time Frame: Baseline, 10 weeks ]
    Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
  • Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms [ Time Frame: Baseline, 10 weeks ]
    PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
  • Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale [ Time Frame: Baseline, 10 weeks ]
    The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.
  • Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale [ Time Frame: 10 weeks ]
    Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.
  • Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, 10 weeks ]
    The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.
  • Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to 10 weeks ]
    The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
  • Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to 10 weeks ]
    The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100.
  • Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist [ Time Frame: 10 weeks, 28 weeks ]
    PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged

    Original Secondary Outcome:

    • Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, 10 weeks ]
    • Change from Baseline to 10 Week Endpoint on the PARS Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms [ Time Frame: Baseline, 10 weeks ]
    • Response Rate at 10 Week Endpoint for Generalized Anxiety Disorder (GAD) Using PARS Severity Score for GAD [ Time Frame: Baseline to10 weeks ]
    • Remission Rate at 10 Week Endpoint for GAD Using CGI-S Scale [ Time Frame: 10 weeks ]
    • Percentage of Patients During the 10 Week Period with Changes in Suicide Risk and Suicide-Related Events (Behavior and/or Ideation) as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through 10 weeks ]
    • Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale [ Time Frame: Baseline, 10 weeks ]
    • Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale [ Time Frame: 10 weeks, 28 weeks ]
    • Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS) [ Time Frame: 10 weeks, 28 weeks ]
    • Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist [ Time Frame: 10 weeks, 28 weeks ]
    • Change from 10 Week to 28 Week Endpoint on the PARS Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms [ Time Frame: 10 weeks, 28 weeks ]
    • Percentage of Patients During the 18 Week Extension Period with Changes in Suicide Risk and Suicide-Related Events (Behavior and/or Ideation) as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 10 weeks through 28 weeks ]


    Information By: Eli Lilly and Company

    Dates:
    Date Received: October 12, 2010
    Date Started: June 2011
    Date Completion:
    Last Updated: January 17, 2014
    Last Verified: January 2014