Maintenance Phase Treatment With Divalproex for Post Trau... | NCT00203385

Studies
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

NCT00203385

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Status

Terminated

Last Update Posted

Apr 26, 2017Actual

Enrollment

20Actual

Phase

Phase 4

Conditions

PTSD

Interventions

Divalproex

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding expired

Expanded Access Info

Start Date

May 2003Actual

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2017

Last Update Posted Date

Apr 26, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lori Davis, MD, Associate Chief of Staff, Tuscaloosa Research & Education Advancement CorporationPrincipal Investigator

Lead Sponsor

Tuscaloosa Research & Education Advancement CorporationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Divalproex	Experimental	Divalproex; oral up to 2000mg/d; open label	Drug: Divalproex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Divalproex	Drug	Depakote up to 2000mg/d	Divalproex	Depakote

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinician Administered PTSD Scale (CAPS)	Clinician-administered rating scale to assess PTSD, 17-items, higher score is more severe, range from zero to 136	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lori L Davis, MD	Tuscaloosa Veterans Affairs Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuscaloosa Research & Education Advancement Corporation		Tuscaloosa	Alabama	35404	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10378177	Background	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.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids