Overview

Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Emory University
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Paroxetine
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.