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A Study in Pediatric Participants With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01226511
First received: October 12, 2010
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anxiety Neuroses
Anxiety States, Neurotic
Neuroses, Anxiety
Interventions: Drug: Duloxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study had 4 periods: Screening period (1-week), acute treatment period (10-week, double-blind period with flexible duloxetine dosing), extension treatment (18-week period, of which 16 weeks were open-label treatment with flexible duloxetine dosing), and a taper period (2 weeks recommended at discontinuation from study any point after Week 2).

Reporting Groups
  Description
Duloxetine/Duloxetine

Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.

Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.

Placebo/Duloxetine

Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.

Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.


Participant Flow for 3 periods

Period 1:   Acute Treatment Period
    Duloxetine/Duloxetine     Placebo/Duloxetine  
STARTED     140 [1]   141 [2]
COMPLETED     108     110  
NOT COMPLETED     32     31  
Adverse Event                 7                 6  
Lack of Efficacy                 2                 1  
Lost to Follow-up                 3                 6  
Parent/caregiver decision                 5                 7  
Protocol Violation                 5                 5  
Withdrawal by Subject                 10                 6  
[1] Thirty-one (31) participants who discontinued acute treatment did not enter the taper period.
[2] Twenty-six (26) participants who discontinued acute treatment did not enter the taper period.

Period 2:   Extension Treatment Period
    Duloxetine/Duloxetine     Placebo/Duloxetine  
STARTED     108 [1]   110 [2]
COMPLETED     81 [3]   83 [4]
NOT COMPLETED     27     27  
Adverse Event                 8                 8  
Lack of Efficacy                 3                 2  
Lost to Follow-up                 4                 3  
Protocol Violation                 2                 2  
Withdrawal by Subject                 1                 3  
Parent/Caregiver Decision                 8                 8  
Sponsor Decision                 1                 1  
[1] Nineteen (19) participants who discontinued extension treatment did not enter the taper period.
[2] Twenty-three (23) participants who discontinued extension treatment did not enter the taper period.
[3] Thirty-nine (39) participants who completed extension treatment did not enter the taper period.
[4] Thirty-five (35) participants who completed extension treatment did not enter the taper period.

Period 3:   Taper Period
    Duloxetine/Duloxetine     Placebo/Duloxetine  
STARTED     51     57  
COMPLETED     46     54  
NOT COMPLETED     5     3  
Adverse Event                 1                 0  
Lost to Follow-up                 2                 2  
Protocol Violation                 1                 0  
Parent/Caregiver Decision                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants, excluding 9 participants from 1 site with major quality issues.

Reporting Groups
  Description
Duloxetine/Duloxetine

Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.

Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.

Placebo/Duloxetine

Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.

Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.

Total Total of all reporting groups

Baseline Measures
    Duloxetine/Duloxetine     Placebo/Duloxetine     Total  
Number of Participants  
[units: participants]
  135     137     272  
Age, Customized  
[units: participants]
     
7 to 11 years     62     66     128  
12 to 17 years     73     71     144  
Gender  
[units: participants]
     
Female     70     75     145  
Male     65     62     127  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     37     40     77  
Not Hispanic or Latino     88     88     176  
Unknown or Not Reported     10     9     19  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     7     6     13  
Asian     1     1     2  
Black or African American     9     10     19  
White     112     111     223  
More than 1 race     6     9     15  
Region of Enrollment  
[units: participants]
     
United States     98     99     197  
Mexico     26     26     52  
South Africa     11     12     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD   [ Time Frame: Baseline, 10 weeks ]

3.  Secondary:   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 ]

4.  Secondary:   Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale   [ Time Frame: Baseline, 10 weeks ]

5.  Secondary:   Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale   [ Time Frame: 10 weeks ]

6.  Secondary:   Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)   [ Time Frame: Baseline, 10 weeks ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   Change From 10-Week to 28-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: 10 weeks, 28 weeks ]

11.  Secondary:   Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale   [ Time Frame: 10 weeks, 28 weeks ]

12.  Secondary:   Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)   [ Time Frame: 10 weeks, 28 weeks ]

13.  Secondary:   Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: 10 weeks up to 28 weeks ]

14.  Secondary:   Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: 10 weeks up to 28 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Nine (9) randomized participants (5 duloxetine, 4 placebo) from 1 site were excluded from efficacy and safety analyses due to major quality issues at that site.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01226511     History of Changes
Other Study ID Numbers: 12929, F1J-MC-HMGI
Study First Received: October 12, 2010
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
South Africa: Department of Health
Mexico: Ministry of Health