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NCT00763178 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT00763178 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 26 participants.
The verdict
NCT00763178, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound. Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD. Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.
Interventions
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00763178
The ClinicalTrials.gov registry entry for NCT00763178 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.
NCT00763178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00763178 about?
NCT00763178 is a clinical study titled "Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)". Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductanc...
What is the current status of trial NCT00763178?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2007-02. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00763178?
The interventions under investigation include: Duloxetine (DRUG).
Who is sponsoring clinical trial NCT00763178?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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