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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108576
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older 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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Information from the National Library of Medicine

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


Locations
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United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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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):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108576    
Other Study ID Numbers: MHBS-026-01
First Posted: April 18, 2005    Key Record Dates
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:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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