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NCT00616655 · ClinicalTrials.gov registry record · Phase 2
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
A Phase 2 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 456
- Enrollment target
NCT00616655: Completed Phase 2 study, sponsored by Sumitomo Pharma America.
NCT00616655 is a Phase 2 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 456 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616655, a Phase 2 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 456 participants
- Enrollment target
Study Summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Primary Outcome
THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The
Interventions
- DRUG Placebo
- DRUG eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00616655 record still lists
NCT00616655 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00616655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616655 about?
NCT00616655 is a clinical study titled "Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects". To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
What is the current status of trial NCT00616655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 456 participants. The study started on 2008-01. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00616655?
The interventions under investigation include: Placebo (DRUG), eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00616655?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616655's enrollment target sits among peer trials
456 84th of 2000 higher than 1,916 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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