Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Placebo; Paroxetine; Positron Emission Tomography (PET) Imaging
Intervention description: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.; Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.; Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PTSD; childhood abuse

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.