Phase 4
N=84
Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT01681849 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score — 31; 30; 20; 25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Paroxetine (Drug); Positron Emission Tomography (PET) Imaging (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score |
31; 30; 20; 25 | — |
| SECONDARY Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM) |
22; 2.68 | — |
Summary
The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
Eligibility Criteria
Inclusion Criteria
- Subjects meet criteria for current PTSD as determined by the Structured Clinical Interview for DSMIV (SCID) interview for PTSD and the Clinician Administered PTSD Scale (CAPS) and have a score of greater than 60 on the CAPS
- history of penetrative sexual abuse which occurred once a month or more, for a period of greater than a year at some time between the ages of 4-13, as assessed by the Early Trauma Inventory (ETI)
- are free of psychotropic medication for four weeks before the study (subjects will not be taken off of medication for the purpose of the study).
- Non-PTSD subjects will be included based on the same criteria with the exception that they do not meet criteria for PTSD.
Exclusion Criteria
- a history of shrapnel or other foreign bodies which would preclude MRI scanning
- meningitis
- traumatic brain injury
- neurological disorder or organic mental disorder
- history of loss of consciousness
- alcohol abuse or substance abuse or dependence based on the SCID within the past 24 months
- positive pregnancy test as measured by a serum beta-HCG or urine pregnancy test on the morning of the PET scan. Women will be counseled about the risks of pregnancy during the course of the study
- current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
- a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
- positive urine toxicology screen
- history of ongoing violence such as domestic abuse as measured by the ETI-lifetime
- post-menopausal status as measured by menstrual history.
- Non-PTSD subjects will additionally be excluded with current major depression or other major psychiatric disorder based on the SCID.
Data sourced from ClinicalTrials.gov (NCT01681849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.