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NCT00266409 · ClinicalTrials.gov registry record · Phase 4
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 Phase 4 study of Generalized Anxiety Disorder and Panic Disorder, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 418
- Enrollment target
- 1
- Study location
NCT00266409: Completed Phase 4 study of Generalized Anxiety Disorder and Panic Disorder, sponsored by UCB Pharma.
NCT00266409 is a Phase 4 study of Generalized Anxiety Disorder and Panic Disorder that has completed, run by UCB Pharma. The registered enrollment target is 418 participants, above the 206-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (103% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00266409, a Phase 4 study of Generalized Anxiety Disorder and Panic Disorder, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 418 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Conditions Studied
Interventions
- DRUG Niravam
- DRUG SSRI/SNRI
Study Locations (1)
Wisconsin
- Schwarz - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-06 |
| Phase | Phase 4 |
What the finished NCT00266409 record still lists
NCT00266409 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, above the 206-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (103% higher).
The record links to 2 conditions, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Niravam is the first listed.
NCT00266409 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00266409 about?
NCT00266409 is a clinical study titled "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". 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...
What is the current status of trial NCT00266409?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 418 participants. The study started on 2005-10. Estimated completion is 2006-06.
What conditions does trial NCT00266409 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder, Panic Disorder.
What interventions are being tested in trial NCT00266409?
The interventions under investigation include: Niravam (DRUG), SSRI/SNRI (DRUG).
Who is sponsoring clinical trial NCT00266409?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00266409 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Generalized Anxiety Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00266409's enrollment target sits among peer trials
418 8th of 48 higher than 41 of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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