Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
- Registration Number
- NCT00108576
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
The purposes of this study are:
* To study the efficacy of divalproex in the treatment of PTSD;
* To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment with divalproex in PTSD.
- Detailed Description
Objective: To study the efficacy of divalproex in the treatment of PTSD. Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex.
Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria, the patient is randomized to either divalproex or placebo for an 8-week duration. During the study a pharmacist maintains the randomization log and administers the placebo or divalproex (500 mg/capsule) in look-a-like tablets. Patients' symptoms, side effects and compliance are assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator increases the medication in 500 mg (one tablet) increments every four days, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 3000 mg/day (6 capsules). The dosing is twice daily, with the higher dose at bedtime. Compliance is assessed by bi-weekly pill count and blinded valproic acid levels at week 4 and week 8. Patients are given supportive clinical management during the clinic visits. An investigator is available by telephone 24 hrs a day in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by the following assessment scales: MADRS (Montgomery-Asberg Depression Rating Scale), Ham-A (Hamilton Anxiety Scale), CGI-s (Clinical Global Impressions-Severity of Illness Scale), CGI-I (Clinical Global Impressions-Improvement Scale), GAF (Global Assessment of Functioning), CAPS (Clinician-Administered PTSD Scale), TOP-8 (Treatment Outcome PTSD Rating Scale), and DTS (Davidson Trauma Scale). Results of this study will be used to evaluate the efficacy of divalproex in the treatment of PTSD.
Significance: Divalproex has shown promise in treating PTSD in open label trials. This study is the next step in proving divalproex's efficacy in the treatment of PTSD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Diagnosis of PTSD, confirmed by MINI (Mini-International Neuropsychiatric Interview) and CAPS
- Age 19 or older
- No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
- Free of psychotropic medication for 2 weeks (except 6 weeks for fluoxetine)
- Clinically normal physical and laboratory examination (lab profile listed below). LFTs (liver function tests) up to 2.5 times the normal limit will be allowed.
- Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, Depo-Provera, or diaphragm with spermicides)
- Signed informed consent
- Male or female of any race or ethnic origin
- Lifetime history of bipolar I, psychotic, or cognitive disorders
- Actively suicidal, homicidal, or psychotic
- History of sensitivity to divalproex
- Unstable general medical conditions
- Score 6 on Question #10 of MADRS
- Women who are pregnant, planning to become pregnant or to breastfeed during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Divalproex Divalproex Arm 1 placebo Look-a-like placebo
- Primary Outcome Measures
Name Time Method Clinician Administered PTSD Scale (CAPS) 8weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tuscaloosa VA Medical Center, Tuscaloosa, AL
🇺🇸Tuscaloosa, Alabama, United States