Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder

NCT01681849 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00000857R01MH056120
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

PTSD; childhood abuse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)

  Baseline, 3 Months Post Treatment

Study Arms (3)

Paroxetine Group

EXPERIMENTAL

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; Other: Positron Emission Tomography (PET) Imaging

Placebo Group

PLACEBO COMPARATOR

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

PTSD Negative

OTHER

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

Interventions

Placebo DRUG

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.

Placebo Group

Paroxetine DRUG

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.

Also known as: Paxil

Paroxetine Group; Placebo Group

Positron Emission Tomography (PET) Imaging OTHER

Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts

PTSD Negative; Paroxetine Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30306, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Paroxetine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. J. Douglas Bremner
• Organization: Emory University

doug.bremner@emory.edu

404-712-9569

Study Officials

• James D. Bremner, MD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Radiology

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 10, 2012
• Study Start: July 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-06

Locations

US (1)