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Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
This study has been completed.
First Received: September 12, 2005   Last Updated: March 16, 2007   History of Changes
Sponsored by: Tuscaloosa Research & Education Advancement Corporation
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203385
  Purpose

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


Condition Intervention Phase
PTSD
Drug: Divalproex sodium
Phase IV

MedlinePlus related topics: Post-Traumatic Stress Disorder
Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD

Estimated Enrollment: 30
Study Start Date: May 2003
Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Study ID Numbers: TREAC Maintenance DVX PTSD, TREAC Maintenance DVX PTSD
Study First Received: September 12, 2005
Last Updated: March 16, 2007
ClinicalTrials.gov Identifier: NCT00203385     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants
Stress Disorders, Post-Traumatic
Stress
Antimanic Agents
Valproic Acid
Anticonvulsants
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Valproic Acid
Stress Disorders, Traumatic
Pharmacologic Actions
Anxiety Disorders
Mental Disorders
Therapeutic Uses
GABA Agents
Stress Disorders, Post-Traumatic
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009