Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2003 |
| End Date: | September 2005 |
Divalproex Sodium in the Treatment of PTSD: A Placebo-Controlled Study
The purposes of this study are:
- To study the efficacy of divalproex in the treatment of PTSD;
- To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment
with divalproex in PTSD.
- To study the efficacy of divalproex in the treatment of PTSD;
- To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment
with divalproex in PTSD.
Objective: To study the efficacy of divalproex in the treatment of 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.
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.
Inclusion Criteria:
- Diagnosis of PTSD, confirmed by MINI (Mini-International Neuropsychiatric Interview)
and CAPS
- Age 19 or older
- No substance abuse/dependence for the previous 6 weeks (except for nicotine and
caffeine)
- Free of psychotropic medication for 2 weeks (except 6 weeks for fluoxetine)
- Clinically normal physical and laboratory examination (lab profile listed below).
LFTs (liver function tests) 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, Depo-Provera, or diaphragm with
spermicides)
- Signed informed consent
- Male or female of any race or ethnic 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 to breastfeed during the study
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