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Women's Post Traumatic Stress Disorder (PTSD) Research Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by VA Boston Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Boston VA Research Institute, Inc.
Boston University
Information provided by:
VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT01304940
First received: February 25, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.


Condition
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Biospecimen Retention:   Samples Without DNA

Urine, blood and saliva samples are taken. Only blood and saliva samples are retained and used to measure stress hormone levels.


Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: June 2013
Detailed Description:

The investigators are trying to understand if there is a relationship between the experience of traumatic events such as those experienced by people with post traumatic stress disorder and reactivity to startling noises or mild threats. So, the investigators are looking at startle reflex, heart rate, and stress hormone responses to short noises and small shocks in people exposed to trauma and who either do or do not have PTSD. Additionally, the investigators will be looking at how the menstrual cycle impacts these processes. The investigators know that women have twice the risk for developing PTSD and some research suggests that stress hormones change during the menstrual cycle and may have an effect on risk.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women, ages 18-55.

Criteria

Inclusion Criteria:

  • Women, ages 18-55 years old who have a regular menstrual cycle and who can come in to participate in the afternoon

Exclusion Criteria:

  • Long-term medications, oral or steroid contraceptives, irregular menstrual cycle
  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: NCT01304940

Locations
United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maggie Bauer    857-364-2790      
Principal Investigator: Suzanne L. Pineles, PhD         
Sponsors and Collaborators
VA Boston Healthcare System
Boston VA Research Institute, Inc.
Boston University
Investigators
Principal Investigator: Suzanne L. Pineles, PhD VA Boston Healthcare System, National Center for PTSD, Boston University School of Medicine
  More Information

No publications provided

Responsible Party: Suzanne Pineles, PhD
ClinicalTrials.gov Identifier: NCT01304940     History of Changes
Other Study ID Numbers: IRB# 2107
Study First Received: February 25, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by VA Boston Healthcare System:
Stress
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014