Phase 3
Completed N=38
Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities
Source: ClinicalTrials.gov NCT00403455 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Clinician Administered PTSD Scale (CAPS) — -21.72 Change in units on a scale
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 focusing on PTSD symptoms, related co-morbidities, treatment outcomes and seeks new approaches to therapy for our Veteran population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
-21.72 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00403455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.