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A Study in Pediatric Participants With Generalized Anxiety Disorder

NCT01226511 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2014-03-05

Study results available
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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).

Conditions

  • Anxiety Neuroses
  • Anxiety States, Neurotic
  • Neuroses, Anxiety

Interventions

DRUG

Duloxetine

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2013-06-30

Countries

  • United States
  • Mexico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226511 on ClinicalTrials.gov