Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

NCT ID: NCT00203385

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2005-03-31

Brief Summary

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

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.

Conditions

PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Divalproex

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

Group Type: EXPERIMENTAL

Divalproex

Intervention Type: DRUG

Depakote up to 2000mg/d

Interventions

Divalproex

Depakote up to 2000mg/d

Intervention Type: DRUG

Other Intervention Names

Depakote

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tuscaloosa Research & Education Advancement Corporation

OTHER

Sponsor Role: lead

Responsible Party

Lori Davis, MD

Associate Chief of Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori L Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Tuscaloosa Veterans Affairs Medical Center

Locations

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10378177 (View on PubMed)

Other Identifiers

TREAC Maintenance DVX PTSD

Identifier Type: -

Identifier Source: org_study_id