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NCT00128401 · ClinicalTrials.gov registry record · Phase 2
Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia
A Phase 2 study of Anxiety and Social Phobia, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT00128401 is a Phase 2 study of Anxiety and Social Phobia that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 48 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00128401, a Phase 2 study of Anxiety and Social Phobia, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the type of learning that is promoted by exposure therapy, a main component of CBT. This study will test whether DCS can improve the effectiveness of CBT for social anxiety. All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT, participants will be randomly assigned (similar to a coin toss) to receive either DCS or a placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions. The pill is taken only on the 12 therapy days. Prior to receiving treatment, participants will be asked to: * participate in interviews to assess diagnosis and how they are doing including mood, degree of nervousness and behavior * have a physical examination, a urine test, and an electrocardiogram (EKG) * undergo tests involving problem-solving and memory * prepare and present a speech to a "virtual audience" using virtual reality goggles * undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months. If a participant does not wish to take medication, study clinicians will help him/her locate psychological care in the community. Participants will be asked to complete a follow-up assessment 3 months after their last CBT session.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG D-Cycloserine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00128401
The ClinicalTrials.gov registry entry for NCT00128401 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (89% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00128401 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00128401 about?
NCT00128401 is a clinical study titled "Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia". This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagn...
What is the current status of trial NCT00128401?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2005-08. Estimated completion is 2012-08.
What conditions does trial NCT00128401 study?
This clinical trial studies the following conditions: Anxiety, Social Phobia, Phobic Disorders.
What interventions are being tested in trial NCT00128401?
The interventions under investigation include: Placebo (DRUG), D-Cycloserine (DRUG).
Who is sponsoring clinical trial NCT00128401?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00128401 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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