Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
NCT ID: NCT01681849
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2009-07-31
2015-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paroxetine Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
Paroxetine
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.
Positron Emission Tomography (PET) Imaging
Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
Placebo Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
Placebo
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.
Paroxetine
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.
Positron Emission Tomography (PET) Imaging
Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
PTSD Negative
Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments. They do not undergo intervention therefore they are assessed at baseline only.
Positron Emission Tomography (PET) Imaging
Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
Interventions
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Placebo
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.
Paroxetine
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.
Positron Emission Tomography (PET) Imaging
Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Emory University
OTHER
Responsible Party
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J. Douglas Bremner, M.D.
Professor of Psychiatry and Radiology
Principal Investigators
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James D. Bremner, MD
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Emory University
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00000857
Identifier Type: -
Identifier Source: org_study_id
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