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

PTSD Clinical Trial

Official title:

Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108576
• Other study ID #: MHBS-026-01
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2005
• Last updated: October 20, 2015
• Start date: October 2003
• Est. completion date: September 2005

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• Divalproex
anticonvulsant; mood stabilizer

Other:
• placebo
Look-a-like placebo

Locations

Country	Name	City	State
United States	Tuscaloosa VA Medical Center, Tuscaloosa, AL	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)		8weeks	No