Conditions: Generalized Anxiety Disorder Panic Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 418
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 2: Panic Disorder: Newly prescribed SSRI or SNRI alone arm 3: Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 4: Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Interventions: intervention 1: Niravam intervention 2: SSRI/SNRI
Intervention descriptions: intervention 1: None intervention 2: Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

Protocol document: