Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
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Purpose
The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.
| Condition | Intervention | Phase |
|---|---|---|
|
PTSD |
Drug: Divalproex sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder |
- The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2003 |
| Study Completion Date: | March 2005 |
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Alabama | |
| Tuscaloosa Research & Education Advancement Corporation | |
| Tuscaloosa, Alabama, United States, 35404 | |
| Principal Investigator: | Lori L Davis, MD | Tuscaloosa VA Medical Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00203385 History of Changes |
| Other Study ID Numbers: | TREAC Maintenance DVX PTSD, TREAC Maintenance DVX PTSD |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 16, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
|
divalproex sodium, depakote, ptsd, long-term ptsd treatments |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 13, 2013