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

This study has been completed.

First Received: December 15, 2005 Last Updated: February 29, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00266409

Purpose

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.

Condition	Intervention	Phase
Generalized Anxiety Disorder Panic Disorder	Drug: Niravam	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by UCB:

Study Start Date:	October 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria: - Generalized Anxiety Disorder or Panic Disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266409

Locations

United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP851
Study First Received:	December 15, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00266409 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Panic Disorder
Alprazolam
Anxiety Disorders
Mental Disorders
Serotonin Uptake Inhibitors

Additional relevant MeSH terms:

Panic Disorder
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 02, 2009