Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
PTSD	Drug: Divalproex; Other: placebo	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	101 participants
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
Study Start Date :	October 2003
Actual Primary Completion Date :	August 2005
Actual Study Completion Date :	September 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Arm 1; Look-a-like placebo	Other: placebo; Look-a-like placebo
Experimental: Arm 2; Divalproex	Drug: Divalproex; anticonvulsant; mood stabilizer

Outcome Measures

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Primary Outcome Measures :

1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	19 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Lori Lynne Davis, MD AB	Tuscaloosa VA Medical Center, Tuscaloosa, AL

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis LL, Davidson JR, Ward LC, Bartolucci A, Bowden CL, Petty F. Divalproex in the treatment of posttraumatic stress disorder: a randomized, double-blind, placebo-controlled trial in a veteran population. J Clin Psychopharmacol. 2008 Feb;28(1):84-8. doi: 10.1097/JCP.0b013e318160f83b.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00108576 History of Changes
Other Study ID Numbers:	MHBS-026-01
First Posted:	April 18, 2005
Last Update Posted:	October 21, 2015
Last Verified:	October 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