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 InhibitionPrimary· 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
Group
Value
95% 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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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 11 June 2024
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.