Status:
COMPLETED
Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)
Lead Sponsor:
Emory University
Conditions:
Posttraumatic Stress Disorder (PTSD)
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is estimated that at least one out of every seven women in our society have been the victim of childhood sexua...
Eligibility Criteria
Inclusion
- Male and female patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for PTSD assessed by the Structured Clinical Interview for DSM IV (SCID).
- All patients with PTSD will be greater than 18 years of age, and will be required to give informed consent.
- Patients will be recruited from newspaper advertisements and fliers.
- All patients must be free of major medical illness on the basis of history and physical examination, lab testing, and electrocardiogram, and must not be actively abusing substances or alcohol.
- Patients should be free of psychotropic medications for four weeks before the study.
Exclusion
- Pregnant and breast-feeding women will not be studied. Female subjects will be required to have a negative pregnancy test before the study. Female subjects of childbearing age will be advised to use barrier contraception for the duration of the study, in addition to other forms of contraception that they may be using.
- Serious medical or neurological illness or a hypersensitivity to paroxetine.
- Past or present steroid use.
- Electroconvulsive therapy (ECT) within the 6 months prior to study entry.
- Organic mental disorders or epilepsy
- History of head trauma
- Cerebral infectious disease or dyslexia.
- History of psychosis, schizophrenia, or eating disorders.
- Active suicidality or homicidality
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00672776
Start Date
May 1 2003
End Date
September 1 2007
Last Update
March 1 2017
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