Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Emory University

Status and phase: Completed; Phase 4

Conditions: PTSD

Treatments: Drug: Paroxetine; Other: Positron Emission Tomography (PET) Imaging; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01681849

IRB00000857

R01MH056120 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

Paroxetine Group

Experimental group

Description:

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.

Treatment:

Other: Positron Emission Tomography (PET) Imaging

Drug: Paroxetine

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Other: Positron Emission Tomography (PET) Imaging

Drug: Paroxetine

PTSD Negative

Other group

Description:

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.

Treatment:

Other: Positron Emission Tomography (PET) Imaging