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Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
J. Douglas Bremner, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT01681849
First received: September 6, 2012
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
PTSD Drug: Placebo Drug: Paroxetine Other: Positron Emission Tomography (PET) Imaging Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by J. Douglas Bremner, M.D., Emory University:

Primary Outcome Measures:
  • Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score [ Time Frame: Baseline, End of Study (Up to 52 Weeks) ]
    The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients.


Secondary Outcome Measures:
  • Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM) [ Time Frame: Baseline, 3 Months Post Treatment ]
    Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group.


Enrollment: 91
Study Start Date: July 2009
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Paxil
Other: 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 Comparator: 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.
Drug: 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.
Drug: 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.
Other Name: Paxil
Other: 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.
Other: 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

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681849

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: James D. Bremner, MD Professor
  More Information

Responsible Party: J. Douglas Bremner, M.D., Professor of Psychiatry and Radiology, Emory University
ClinicalTrials.gov Identifier: NCT01681849     History of Changes
Other Study ID Numbers: IRB00000857
R01MH056120 ( U.S. NIH Grant/Contract )
Study First Received: September 6, 2012
Results First Received: November 28, 2016
Last Updated: June 26, 2017

Keywords provided by J. Douglas Bremner, M.D., Emory University:
PTSD
childhood abuse

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 21, 2017