Clinical trial NCT00203385: Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Official title: Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: PTSD
Keywords: divalproex sodium, depakote, ptsd, long-term ptsd treatments
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinician Administered PTSD Scale Subscores
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa Research & Education Advancement Corporation
state: Alabama
Study officials:
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Lori L Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.