Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Clinician Administered PTSD Scale (CAPS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open label
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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 breastfeed during the study
Arms & Interventions
Divalproex
Divalproex; oral up to 2000mg/d; open label
Intervention: Divalproex (Drug)
Outcomes
Primary Outcomes
Clinician Administered PTSD Scale (CAPS)
Time Frame: 24 weeks
Clinician-administered rating scale to assess PTSD, 17-items, higher score is more severe, range from zero to 136
Secondary Outcomes
- Clinician Administered PTSD Scale Subscores(24 weeks)
Investigators
Lori Davis, MD
Associate Chief of Staff
Tuscaloosa Research & Education Advancement Corporation