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
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.
Timeline
- Start
- 2005-10
- Primary completion
- 2006-06
- Completion
- 2006-06
Outcome
Mixed primary results
paper There was no statistical difference between treatment groups in time to response in the ITT population; PMID 20877555 ↗
registry analysis (superiority or other test); Panic: Niravam+SSRI/SNRI vs Panic: SSRI/SNRI Alone; p = 0.044; Generalized Wilcoxon Test NCT00266409 ↗
paper however, a prospectively defined per protocol analysis revealed a statistically significant earlier onset of effect in subjects receiving SSRI/SNRI plus alprazolam ODT (P<0.05). PMID 20877555 ↗
paper There was no statistical difference between groups in the primary efficacy variable of time to response on the HAM-A. PMID 20877556 ↗
Publications
- Results Katzelnick DJ, Saidi J, Vanelli MR, Jefferson JW, Harper JM, McCrary KE. Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):39-49.
- Results Rapaport MH, Skarky SB, Katzelnick DJ, Dewester JN, Harper JM, McCrary KE. Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):50-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alprazolam | Small molecule | — | Oral |