Status:
COMPLETED
Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Dr. Wang's merit review is aimed at providing a better understanding of the relationship between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat stress, specifically f...
Detailed Description
Background: Post-traumatic Stress Disorder (PTSD), a debilitating condition that develops following exposure to trauma, is highly prevalent in military personnel and veterans due to high risk of traum...
Eligibility Criteria
Inclusion
- Male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S;
- A minimum 6-month duration of PTSD illness; 3)CGI-S score of 4 or higher and a total CAPS-2 severity score of 50 or higher at the baseline visit;
- Homozygous for either the S/S or L/L 5-HTT;
- Females must not be pregnant or lactating and must agree to an acceptable form of contraception while receiving study medication and for 1 month after.
Exclusion
- Presence of any other primary axis I disorder (concurrent depression will be permitted if it is judged to be secondary to development for PTSD);
- Suicide ideation or attempts within the past 3 months;
- Alcohol or substance abuse or dependence in the past six months;
- Evidence of clinically significant hepatic or renal disease;
- Previous seizure disorder or condition predisposing to seizures, or on medications that might lower the seizure threshold
- Any acute or unstable medical condition that might interfere with the safe conduct of the study;
- Intolerance or hypersensitivity to citalopram or any other SSRI;
- Treatment with a monoamine oxidase inhibitor within 14 days of initiating the study;
- Concomitant treatment with serotonin agonists, other SSRIs, meperidine, tramadol or other medication as determined by the study clinician.
- PTSD symptoms in need of immediate treatment as determined by clinical assessment from a psychiatrist not affiliated with the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00403455
Start Date
October 1 2006
End Date
July 1 2011
Last Update
July 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799