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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108576
First received: April 15, 2005
Last updated: August 14, 2013
Last verified: August 2013
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

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
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108576

Locations
United States, Alabama
Tuscaloosa VAMC
Tuscaloosa, Alabama, United States, 35405
Sponsors and Collaborators
Investigators
Principal Investigator: Lori Lynne Davis, MD AB Tuscaloosa VAMC
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108576     History of Changes
Other Study ID Numbers: MHBS-026-01
Study First Received: April 15, 2005
Last Updated: August 14, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
anticonvulsant
anxiety
divalproex
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Anticonvulsants
Valproic Acid
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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 28, 2014