Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by:
Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00203385
First received: September 12, 2005
Last updated: March 16, 2007
Last verified: March 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Resource links provided by NLM:


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:
ClinicalTrials.gov Identifier: NCT00203385     History of Changes
Other Study ID Numbers: TREAC Maintenance DVX PTSD, TREAC Maintenance DVX PTSD
Study First Received: September 12, 2005
Last Updated: March 16, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
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 April 21, 2014