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Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
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Purpose
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 | Intervention | Phase |
|---|---|---|
| PTSD | Drug: Divalproex Other: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study |
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8weeks ]
| Enrollment: | 101 |
| Study Start Date: | October 2003 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm 1
Look-a-like placebo
|
Other: placebo
Look-a-like placebo
|
|
Experimental: Arm 2
Divalproex
|
Drug: Divalproex
anticonvulsant; mood stabilizer
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00108576 History of Changes |
| Other Study ID Numbers: |
MHBS-026-01 |
| Study First Received: | April 15, 2005 |
| Last Updated: | October 20, 2015 |
Keywords provided by VA Office of Research and Development:
|
anticonvulsant anxiety divalproex PTSD |
Additional relevant MeSH terms:
|
Valproic Acid Anticonvulsants Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents |
Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on August 22, 2017