NCT00638885

Brief Summary

The purpose of this project is to measure brain markers and cognitive factors in twins with a history of military service with and without PTSD, and to follow them over time and measure changes in brain function and cognitive variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 15, 2015

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

March 12, 2008

Results QC Date

January 8, 2015

Last Update Submit

January 8, 2015

Conditions

Keywords

PTSDhippocampustwins

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological Testing of Memory

    Percent retention on the Wechsler Memory Scale - Logical

    2 days

Study Arms (1)

Group 1

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twins with history of military service during Vietnam era with and without PTSD

You may qualify if:

  • All twins will be required to give written informed consent.
  • Subjects will be included with a history of Vietnam Era service.
  • All subjects must be free of major medical illness on the basis of history and physical examination, lab testing, and electrocardiogram.

You may not qualify if:

  • Subjects will be excluded with a history of shrapnel or other foreign bodies that would preclude MRI scanning, history of loss of consciousness, or neuroleptics, sedative or benzodiazepine medication usage within the previous four weeks.
  • Subjects will also be excluded if based on the SCID interview they have comorbid:
  • schizophrenia;
  • schizoaffective disorder;
  • bulimia or anorexia, or
  • bipolar disorder.
  • Subjects will also be excluded with a history of blast injury with associated traumatic brain injury.
  • In addition, subjects will be excluded with a history of alcohol or substance abuse/dependence within the past year. We will use the strategy used in prior MRI studies and use multivariate analyses to examine the contribution of past histories of alcohol and substance abuse (as measured with the Addiction Severity Index) and depression symptom level (as measured with the Hamilton Depression Scale) to the outcomes of interest.
  • Subjects will be excluded from the study if they present with a history of serious medical or neurological illness, or as a result of routine laboratory studies, history of asthma, steroid usage, seizure disorder, or prenatal/perinatal substance exposure or trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood for genetic testing, blood samples and urine and saliva collections

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
J Douglas Bremner MD
Organization
Atlanta VAMC

Study Officials

  • Doug Bremner, MD

    Atlanta VA Medical and Rehab Center, Decatur

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

April 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

January 15, 2015

Results First Posted

January 15, 2015

Record last verified: 2015-01

Locations