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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00108576 |
The purposes of this study are:
Condition | Intervention | Phase |
---|---|---|
PTSD |
Drug: Divalproex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | March 2005 |
Objective: To study the efficacy of divalproex in the treatment of PTSD. To study the plasma GABA levels before and after treatment with divalproex in PTSD.
Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex.
Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria, the patient is randomized to either divalproex or placebo for an 8-week duration. During the study a pharmacist maintains the randomization log and administers the placebo or divalproex (500 mg/capsule) in look-a-like tablets. Patients' symptoms, side effects and compliance are assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator increases 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 (6 capsules). The dosing is twice daily, with the higher dose at bedtime. Compliance is assessed by bi-weekly pill count and blinded valproic acid levels at week 4 and week 8. 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 following assessment scales: MADRS (Montgomery-Asberg Depression Rating Scale), Ham-A (Hamilton Anxiety Scale), CGI-s (Clinical Global Impressions-Severity of Illness Scale), CGI-I (Clinical Global Impressions-Improvement Scale), GAF (Global Assessment of Functioning), CAPS (Clinician-Administered PTSD Scale), TOP-8 (Treatment Outcome PTSD Rating Scale), and DTS (Davidson Trauma Scale). Results of this study will be used to evaluate the efficacy of divalproex in the treatment of PTSD.
Significance: Divalproex has shown promise in treating PTSD in open label trials. This study is the next step in proving divalproex's efficacy in the treatment of PTSD.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | MHBS-026-01 |
Study First Received: | April 15, 2005 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00108576 |
Health Authority: | United States: Federal Government |
PTSD anxiety divalproex anticonvulsant |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic |
Stress Valproic Acid Stress Disorders, Traumatic |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |