Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

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

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Drug: Divalproex

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • Tuscaloosa Research & Education Advancement Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Divalproex; Divalproex; oral up to 2000mg/d; open label	Drug: Divalproex; Depakote up to 2000mg/d; Other Names: Depakote

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale (CAPS)	Clinician-administered rating scale to assess PTSD, 17-items, higher score is more severe, range from zero to 136	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tuscaloosa Research & Education Advancement Corporation

Publications and helpful links

General Publications

• Clark RD, Canive JM, Calais LA, Qualls CR, Tuason VB. Divalproex in posttraumatic stress disorder: an open-label clinical trial. J Trauma Stress. 1999 Apr;12(2):395-401. doi: 10.1023/A:1024797014210.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2003
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: divalproex sodium, depakote, ptsd, long-term ptsd treatments
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: TREAC Maintenance DVX PTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO