Clinical trial NCT01681849: Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
Official title: Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PTSD
Keywords: PTSD
childhood abuse
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-09-10
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The main purpose of this study was to look at the effects of paroxetine on PTSD symptoms and brain function in women with posttraumatic stress disorder (PTSD) related to childhood abuse. Participants underwent baseline assessment with of PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and brain function during exposure to traumatic scripts of childhood abuse. Participants then were treated in a randomized double-blind fashion with paroxetine or placebo for three months, followed by a repeat of these assessments.

Specific Aims of this proposal were therefore to:

* Assess the effects of paroxetine on PTSD symptoms
* Assess the effects of paroxetine on brain function in conjunction with exposure to traumatic scripts using positron emission tomography (PET) with O-15 water

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.

Primary outcomes:
measure: Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score
timeFrame: Baseline, End of Study (Up to 52 Weeks)
Secondary outcomes:
measure: Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)
timeFrame: Baseline, 3 Months Post Treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Professor
name: James D. Bremner, MD
role: PRINCIPAL_INVESTIGATOR
References: