deltatrials
Terminated PHASE4 INTERVENTIONAL 1-arm NCT00203385

Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Sponsor: Tuscaloosa Research & Education Advancement Corporation

Conditions PTSD
Interventions Divalproex
Updated 7 times since 2017 Last updated: Apr 24, 2017 Started: May 31, 2003 Primary completion: Mar 31, 2005 Completion: Mar 31, 2005
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Funding expired

This PHASE4 trial investigates PTSD and is currently terminated or withdrawn. Tuscaloosa Research & Education Advancement Corporation leads this study, which shows 7 recorded versions since 2003 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~May 2017 · 4 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Present [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

Show 2 earlier versions
  1. May 2017 — Jun 2018 [monthly]

    Terminated PHASE4

    Status: CompletedTerminated

  2. Jan 2017 — May 2017 [monthly]

    Completed PHASE4

    First recorded

May 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tuscaloosa Research & Education Advancement Corporation
Data source: Tuscaloosa Research & Education Advancement Corporation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations