Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
J. Douglas Bremner, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT01681849
First received: September 6, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
PTSD
Drug: Placebo
Drug: Paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Emory University:

Primary Outcome Measures:
  • PTSD symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    PTSD symptoms as measured with the Clinician Administered PTSD Scale (CAPS)


Secondary Outcome Measures:
  • Brain Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in brain functional response to reminders of childhood abuse.


Estimated Enrollment: 144
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo given at variable dose for three months. Subjects undergo brain imaging with O-15 radiolabelled water during exposure to reminders of childhood abuse before and after treatment.
Drug: Placebo
Following the double blind phase, subjects are treated with open label paroxetine at a variable dosage of 10-40 mg followed by PET imaging of the brain with O-15 radiolabelled water.
Other Name: sugar pill manufactured to look like paroxetine
Drug: Paroxetine
Following the double blind phase, subjects are treated with open label paroxetine at a variable dosage of 10-40 mg followed by PET imaging of the brain with O-15 radiolabelled water.
Other Name: Paxil
Experimental: Paroxetine
Paroxetine given in a double-blind fashion at a variable dosage of 10-40 mg per day over three months, with positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water before and after treatment.
Drug: Placebo
Following the double blind phase, subjects are treated with open label paroxetine at a variable dosage of 10-40 mg followed by PET imaging of the brain with O-15 radiolabelled water.
Other Name: sugar pill manufactured to look like paroxetine
Drug: Paroxetine
Following the double blind phase, subjects are treated with open label paroxetine at a variable dosage of 10-40 mg followed by PET imaging of the brain with O-15 radiolabelled water.
Other Name: Paxil

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  More Information

No publications provided

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, R01MH56120
Study First Received: September 6, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
PTSD
childhood abuse

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014