Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

NCT00203385 | Terminated Phase 4

• 1 other identifier: TREAC Maintenance DVX PTSD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTSD

Keywords

divalproex sodium, depakote, ptsd, long-term ptsd treatments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinician Administered PTSD Scale Subscores

  24 weeks

Study Arms (1)

Divalproex

EXPERIMENTAL

Divalproex; oral up to 2000mg/d; open label

Drug: Divalproex

Interventions

Divalproex DRUG

Depakote up to 2000mg/d

Also known as: Depakote

Divalproex

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PTSD, confirmed by MINI and CAPS.
• Participation in the placebo-controlled acute phase study with divalproex for PTSD
• Age 19 or older
• No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
• Clinically normal physical and laboratory examination (lab profile listed below). LFTs 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, DepoProvera, or diaphragm with spermicide)
• Signed informed consent
• Male or female, any race or ethic origin

You may not qualify if:

• 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 breastfeed during the study

Sponsors & Collaborators

• Tuscaloosa Research & Education Advancement Corporation: lead

Study Sites (1)

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

• 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.

  PMID: 10378177 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Lori L Davis, MD

  Tuscaloosa Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Staff

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)