Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681849
• Other study ID #: IRB00000857
• Secondary ID: R01MH056120
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2012
• Last updated: June 26, 2017
• Start date: July 2009
• Est. completion date: July 2015

Study information

• Verified date: June 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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:
• 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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score	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.	Baseline, End of Study (Up to 52 Weeks)
Secondary	Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)	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.	Baseline, 3 Months Post Treatment