Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
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|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|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||September 2005|
Placebo Comparator: Arm 1
Experimental: Arm 2
anticonvulsant; mood stabilizer
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|