divalproex sodium in the treatment of ptsd (post-traumatic stress disorder)

Conditions: PTSD

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.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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

Keywords: anticonvulsant anxiety divalproex ptsd