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NCT00383786 · ClinicalTrials.gov registry record · Phase 2
Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder
A Phase 2 study of PTSD, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT00383786: Completed Phase 2 study of PTSD, sponsored by Baylor College of Medicine.
NCT00383786 is a Phase 2 study of PTSD that has completed, run by Baylor College of Medicine. The registered enrollment target is 47 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383786, a Phase 2 study of PTSD, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD). People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures: Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period. Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits. * Interviews, self report questionnaires and psychiatric rating scales at every visit. * Physical examination, blood and urine tests. Blood is drawn up to 10 times during the study. Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment.
Primary Outcome
The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 "B" symptom, 3 "C" symptoms, and 2 "D" sy
Conditions Studied
Interventions
- DRUG NK1 Antagoist (GR205171)
- PROCEDURE Psychophysiology (Trauma Script)
- PROCEDURE Psychophysiology (Verbal Threat)
- PROCEDURE Psychophysiology (Fear Conditioning)
- PROCEDURE Psychophysiology (Affective Modulation)
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
New York
- Mt. Sinai Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00383786 record still lists
NCT00383786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (84% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 5 interventions - of which NK1 Antagoist (GR205171) is the first listed.
NCT00383786 reports a single indexed study location in Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT00383786 about?
NCT00383786 is a clinical study titled "Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder". This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD). People between 18 and 65 years of age who have been diagnosed wit...
What is the current status of trial NCT00383786?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2006-09. Estimated completion is 2009-06.
What conditions does trial NCT00383786 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT00383786?
The interventions under investigation include: NK1 Antagoist (GR205171) (DRUG), Psychophysiology (Trauma Script) (PROCEDURE), Psychophysiology (Verbal Threat) (PROCEDURE), Psychophysiology (Fear Conditioning) (PROCEDURE), Psychophysiology (Affective Modulation) (PROCEDURE).
Who is sponsoring clinical trial NCT00383786?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00383786 being conducted?
This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
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 NCT00383786's enrollment target sits among peer trials
47 100th of 154 higher than 55 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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.
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