NCT00266409

Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

A Multicenter, Randomized, Open-label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (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 (GAD)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.

Conditions

• Generalized Anxiety Disorder
• Panic Disorder

Interventions

Type	Name	Description
DRUG	Niravam
DRUG	SSRI/SNRI	Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-12-16
• Last updated: 2014-10-27
• Results posted: 2009-10-02

Locations

1 site across 1 country: United States