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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PTSD

Intervention: Placebo (Drug); Paroxetine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Emory University

Summary

The purpose of this study is 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.

Clinical Details

Official title: Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: PTSD symptoms

Secondary outcome: Brain Function

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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.

Locations and Contacts

Emory University, Atlanta, Georgia 30306, United States
Additional Information

Starting date: July 2009
Last updated: January 16, 2015

Page last updated: August 23, 2015

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