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NCT00591565 · ClinicalTrials.gov registry record · NA
An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants
A NA study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT00591565: Completed NA study, sponsored by State University of New York - Upstate Medical University.
NCT00591565 is a NA study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591565, a NA study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent
Primary Outcome
this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).
Interventions
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT00591565 record still lists
NCT00591565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Acamprosate is the first listed.
NCT00591565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00591565 about?
NCT00591565 is a clinical study titled "An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants". This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of...
What is the current status of trial NCT00591565?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2006-06. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00591565?
The interventions under investigation include: Acamprosate (DRUG).
Who is sponsoring clinical trial NCT00591565?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591565's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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