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Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00203385
Recruitment Status : Terminated (Funding expired)
First Posted : September 20, 2005
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.

Condition or disease Intervention/treatment Phase
PTSD Drug: Divalproex Phase 4

Detailed Description:
Patients who have participated in the 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex for PTSD and have signed informed consent will be enrolled in a 24-week open-label divalproex continuation phase trial. Patients' symptoms, side effects and compliance will be assessed every two weeks for 4 weeks, then every 4 weeks, thereafter, up to 24-weeks. Based on symptomology and occurrence of side effects, the investigator will titrate 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. The dosing is twice daily, with the higher dose at bedtime. Compliance will be assessed by monthly pill count and valproic acid levels at the week(s) 4, 12 and 24. 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 structured rating scales for depression, global function and assessment and PTSD. Results of this study will be used to evaluate the long-term efficacy of divalproex in the maintenance treatment of PTSD.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Official Title: Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Actual Study Start Date : May 2003
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Divalproex
Divalproex; oral up to 2000mg/d; open label
Drug: Divalproex
Depakote up to 2000mg/d
Other Name: Depakote


Outcome Measures

Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 24 weeks ]
    Clinician-administered rating scale to assess PTSD, 17-items, higher score is more severe, range from zero to 136


Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale Subscores [ Time Frame: 24 weeks ]
    Clinician-administered rating scale to assess PTSD clusters of re-experiencing, avoidance and emotional numbing, and hyperarousal; higher score is more severe.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of PTSD, confirmed by MINI and CAPS.
  2. Participation in the placebo-controlled acute phase study with divalproex for PTSD
  3. Age 19 or older
  4. No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
  5. Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.
  6. Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, DepoProvera, or diaphragm with spermicide)
  7. Signed informed consent
  8. Male or female, any race or ethic origin

Exclusion Criteria:

  1. Lifetime history of bipolar I, psychotic, or cognitive disorders
  2. Actively suicidal, homicidal, or psychotic
  3. History of sensitivity to divalproex
  4. Unstable general medical conditions
  5. Score ≥ 6 on Question #10 of MADRS
  6. Women who are pregnant, planning to become pregnant or breastfeed during the study
Contacts and Locations

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): NCT00203385


Locations
United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Investigators
Principal Investigator: Lori L Davis, MD Tuscaloosa VA Medical Center
More Information

Publications:
Responsible Party: Lori Davis, MD, Associate Chief of Staff, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203385     History of Changes
Other Study ID Numbers: TREAC Maintenance DVX PTSD
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation:
divalproex sodium, depakote, ptsd, long-term ptsd treatments

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-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