PTSDPhase 4NCT00203385
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
A Phase 4 study testing Divalproex in people with PTSD, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Divalproex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, 35404
About this study
The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.
Read the 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.
- Conditions
- PTSD
- Being tested
- Divalproex
- Keywords
- divalproex sodium, depakote, ptsd, long-term ptsd treatments
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivalproexDrug
Also called Depakote
Depakote up to 2000mg/d
| Study group | Role | What they receive |
|---|---|---|
| Divalproex | Experimental | Divalproex; oral up to 2000mg/d; open label Receives: Drug: Divalproex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Clinician-administered rating scale to assess PTSD, 17-items, higher score is more severe, range from zero to 136
Measured: 24 weeks
Secondary outcomes (1)
Clinician Administered PTSD Scale Subscores
Clinician-administered rating scale to assess PTSD clusters of re-experiencing, avoidance and emotional numbing, and hyperarousal; higher score is more severe.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMar 2005
- Study completionMar 2005
Why it stopped: Funding expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203385
- Sponsor's protocol ID
- TREAC Maintenance DVX PTSD
- Status last verified
- Apr 2017
- First submitted
- 12 Sep 2005
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clark RD, Canive JM, Calais LA, Qualls CR, Tuason VB. Divalproex in posttraumatic stress disorder: an open-label clinical trial. J Trauma Stress. 1999 Apr;12(2):395-401. doi: 10.1023/A:1024797014210.
PubMed 10378177
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00203385
- Acronym / sponsor ID
- TREAC Maintenance DVX PTSD
- Conditions
- PTSD
- Keywords
- divalproex sodium, depakote, ptsd, long-term ptsd treatments
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding expired
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Study start
- May 2003 (actual)
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Divalproex | Experimental | Drug: DivalproexDivalproex; oral up to 2000mg/d; open label |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DivalproexAlso: DepakoteDepakote up to 2000mg/d | Drug | Divalproex |
Primary outcome
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
1 secondary outcome
Clinician Administered PTSD Scale Subscores
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Funding expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 10378177Clark RD, Canive JM, Calais LA, Qualls CR, Tuason VB. Divalproex in posttraumatic stress disorder: an open-label clinical trial. J Trauma Stress. 1999 Apr;12(2):395-401. doi: 10.1023/A:1024797014210.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori L Davis, MD principal investigator
Tuscaloosa Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Divalproex in people with PTSD, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.