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NCT01304940

Women's Post Traumatic Stress Disorder (PTSD) Research Study

Completed Results posted Last updated 11 June 2024
What this trial tests

trial in Posttraumatic Stress Disorder in 50 participants. Completed in 1 February 2013.

Timeline
1 December 2008
Primary endpoint
1 February 2012
1 February 2013

Quick facts

Lead sponsorVA Office of Research and Development
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date1 December 2008
Primary completion1 February 2012
Estimated completion1 February 2013
Sites1 location across United States

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 55, female only, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prepulse Inhibition Primary · This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.

To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below: PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials. A negative value on this PPI ratio is indicative of greater prepulse

GroupValue95% CI
PTSD Group-.19± .04
Trauma Control Group-.31± .04

Sponsor's own description

The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Posttraumatic Stress Disorder

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01304940.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing