Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
|ClinicalTrials.gov Identifier: NCT00108576|
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : October 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Drug: Divalproex Other: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study|
|Study Start Date :||October 2003|
|Primary Completion Date :||August 2005|
|Study Completion Date :||September 2005|
Placebo Comparator: Arm 1
Experimental: Arm 2
anticonvulsant; mood stabilizer
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108576
|United States, Alabama|
|Tuscaloosa VA Medical Center, Tuscaloosa, AL|
|Tuscaloosa, Alabama, United States, 35404|
|Principal Investigator:||Lori Lynne Davis, MD AB||Tuscaloosa VA Medical Center, Tuscaloosa, AL|