Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT01681849

Run by

Emory University

People needed

91

Starts

2009-07-01

Expected to finish

2015-07-01

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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