Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
1 other identifier
interventional
101
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 15, 2005
CompletedFirst Posted
Study publicly available on registry
April 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedOctober 21, 2015
October 1, 2015
1.8 years
April 15, 2005
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale (CAPS)
8weeks
Study Arms (2)
Arm 1
PLACEBO COMPARATORLook-a-like placebo
Arm 2
EXPERIMENTALDivalproex
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404, United States
Related Publications (1)
Davis LL, Davidson JR, Ward LC, Bartolucci A, Bowden CL, Petty F. Divalproex in the treatment of posttraumatic stress disorder: a randomized, double-blind, placebo-controlled trial in a veteran population. J Clin Psychopharmacol. 2008 Feb;28(1):84-8. doi: 10.1097/JCP.0b013e318160f83b.
PMID: 18204347DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Lynne Davis, MD AB
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2005
First Posted
April 18, 2005
Study Start
October 1, 2003
Primary Completion
August 1, 2005
Study Completion
September 1, 2005
Last Updated
October 21, 2015
Record last verified: 2015-10