Neural Circuits in Women With Abuse and PTSD
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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 improvment in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
| Condition | Intervention | Phase |
|---|---|---|
|
PTSD |
Drug: Paroxetine Drug: O-15 labelled water |
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 PTSD |
- PTSD symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]PTSD symptoms as measured with the Clinician Administered PTSD Scale (CAPS)
- 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 2013 |
| Estimated Primary Completion Date: | July 2013 (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: Paroxetine
Other Name: Paxil
Drug: O-15 labelled water
radiolabelled water used in PET imaging of brain functional responses to reminders of childhood abuse. Performed before and after treatment with paroxetine or placebo.
Other Names:
|
|
Experimental: Paroxetine
paroxetine 10-40 mg 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: Paroxetine
Other Name: Paxil
Drug: O-15 labelled water
radiolabelled water used in PET imaging of brain functional responses to reminders of childhood abuse. Performed before and after treatment with paroxetine or placebo.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
PTSD subjects will be included who: 1) meet criteria for current PTSD as determined by the Structured Clinical Interview for DSMIV (SCID) interview for PTSD391 and the Clinician Administered PTSD Scale (CAPS); 2) have a score of greater than 60 on the CAPS; 3) have a 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);328 4) 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). Independent verification of abuse will be sought based on either court records, family or friends, foster parents, emergency room records, medical records, or child protection agency records (see discussion below in "Rationale"). Non-PTSD subjects will be included based on the same criteria with the exception that they do not meet criteria for PTSD.
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Exclusion Criteria:
- Women will be excluded with: 1) a history of shrapnel or other foreign bodies which would preclude MRI scanning; 2) meningitis; 3) traumatic brain injury; 4) neurological disorder or organic mental disorder; 5) history of loss of consciousness; 6) alcohol abuse or substance abuse or dependence based on the SCID within the past 24 months; 7) positive pregnancy test as measured by a serum beta-HCG on the morning of the PET scan. Women will be counseled about the risks of pregnancy during the course of the study; 8) current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID; 9) a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness; 10) 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); 11) positive urine toxicology screen; 12) history of ongoing violence such as domestic abuse as measured by the ETI-lifetime; 13) 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| Contact: Lai Reed, MBA | (404) 712-9571 | jreed6@emory.edu |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30306 | |
| Contact: Lai Reed, MBA 404-712-9571 jreed6@emory.edu | |
| Principal Investigator: James D Bremner, MD | |
More Information
Additional 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: | R01MH56120 |
| Study First Received: | September 6, 2012 |
| Last Updated: | September 6, 2012 |
| 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 Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013