Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

PTSD Clinical Trial

Official title:

Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00203385
• Other study ID #: TREAC Maintenance DVX PTSD
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 24, 2017
• Start date: May 2003
• Est. completion date: March 2005

Study information

• Verified date: April 2017
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Divalproex
Depakote up to 2000mg/d

Locations

Country	Name	City	State
United States	Tuscaloosa Research & Education Advancement Corporation	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Clark RD, Cañive 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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