Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam(TM) and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disorder; Panic Disorder
Intervention: Niravam (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
Summary
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in
symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed SSRI/SNRI to
that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least
18 years of age and positive for Generalized Anxiety Disorder or Panic Disorder. Subjects
will be randomized to receive concomitant Niravam and an SSRI/SNRI or an SSRI/SNRI alone
during the study. Most symptom evaluations will be done using an automated phone interview
system. There are 4 clinic visits.
Clinical Details
Official title: A Multicenter, Randomized, Open-Label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam(TM) and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Generalized Anxiety Disorder or Panic Disorder
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Additional Information
Starting date: October 2005
Ending date: June 2006
Last updated: February 29, 2008
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