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Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study

Primary Purpose

Combat Posttraumatic Stess Disorder, Mild Traumatic Brain Injury

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lithium Carbonate
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Combat Posttraumatic Stess Disorder focused on measuring Posttraumatic Stess Disorder, Lithium

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Combat Veterans seeking treatment at the Denver Veterans Affairs Medical Center. Subjects must be between the ages of 18-50 years old, have a diagnosis of Posttraumatic Stress Disorder and assessed with a Clinician Administered Posttraumatic Stress Disorder Scale scoring greater than 15 on the Clinician Administered Posttraumatic Stress Disorder Scale -D. Subjects may have a history mild traumatic brain injury. Subjects must also have a stable medical condition to be considered for the study. Both males and females will be included, and no exclusions will be made for race or ethnicity.

Exclusion Criteria:

  • Subjects with substance dependence disorder less than two months prior to study enrollment; history of bipolar, psychotic and/or cognitive disorders; history of moderate-to-severe traumatic brain injury; seizure disorder; sensitivity to lithium or contraindications to lithium treatment; will not be included in this study.
  • Subjects currently enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, will not be included until the subject has completed their participation in the other study.
  • Women, who are pregnant, suspect that they are pregnant, or planning to become pregnant will not be enrolled into the study.
  • Subjects declared incompetent by the Veterans Health Administraytion or other legal authority will not be included for participation in this study. Additionally, research team members involved in the consenting process of the study will not enroll subjects whom appear incompetent to consent. Recruited subjects unable to comprehend the nature of the study, their involvement & possible risks, described to them during the consent/enrollment process, will not be allowed to participate in the study for the respect of the volunteering subject, their safety, & to ensure that volunteering subjects do not experience any coercion to participate in this study.

Sites / Locations

  • Denver Veterans Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lithium Augmentation

Arm Description

Open-label trial - active treatment

Outcomes

Primary Outcome Measures

Udvalg for Kliniske Undersogelser Side Effect Rating Scale
This is a comprehensive side effect rating scale designed to capture the side effects associated with psychotropic medications in both clinical trials and routine clinical use. Its reliability and validity are well established and it has been used in a variety of clinical trials.Forty-eight items are grouped into four categories: Psychic, Neurological, Autonomic, and Other. Causal relationship to each item is rated as impossible, possible, or probable.

Secondary Outcome Measures

Clinician Administered Posttraumatic Stress Disorder Scale
Structured interview scale developed to assess the type and severity of Diagnostic and Statistical Manual-III-R posttraumatic stress disorder symptoms with scoring that can be modified for Diagnostic and Statistical Manual-IV criteria. It consists of 17 interviewer-rated items that cover the core symptoms of posttraumatic stress disorder according to the Diagnostic and Statistical Manual criteria. It includes 5 global rating scales that reflect the impact of symptoms on social and occupational functioning, general severity, and recent changes in severity, and the assessor's evaluation of the validity of the patient's report.
Beck Scale for Suicide Ideation
This is a 21-item, self-report version of the original Scale for Suicide Ideation, a clinician-administered, semi-structured interview (Beck, Kovacs & Weissman, 1979). Response options range from 0-2 (lowest to highest severity) for each item on the scale, with a total scale ranging from 0-38. Items 20 and 21 refer to past suicide attempts and do not contribute to the overall score.

Full Information

First Posted
July 25, 2012
Last Updated
January 5, 2016
Sponsor
VA Eastern Colorado Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01754883
Brief Title
Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study
Official Title
Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Eastern Colorado Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the effectiveness of adding lithium carbonate (lithium) to treatment for combat-related post traumatic stress disorder in combat veterans. The goal of this study is to establish that lithium is a practical and tolerable treatment option for veterans with combat posttraumatic stress disorder.
Detailed Description
Few evidence-based treatment options exist for patients with posttraumatic stress disorder inadequately responsive to standard medication treatments, such as psychopharmacology with serotonin specific reuptake inhibitors. Although many agents have been studied in the management of posttraumatic stress disorder, including antidepressants, mood stabilizers, and atypical antipsychotics, augmentation of existing treatments with lithium remains almost wholly unexplored. Lithium augmentation may represent a worthwhile treatment option in light of its broad clinical utility, including reported clinical benefits for aggression, suicidality, and mood; its apparent effects on mediotemporal and prefrontal brain areas; and the neurobiology of posttraumatic stress disorder. Primary Aim: Establish the safety and tolerability of lithium augmentation of psychopharmacological treatment as usual for combat veterans with posttraumatic stress disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Combat Posttraumatic Stess Disorder, Mild Traumatic Brain Injury
Keywords
Posttraumatic Stess Disorder, Lithium

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium Augmentation
Arm Type
Experimental
Arm Description
Open-label trial - active treatment
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
Oral Lithium carbonate to target serum levle of 0.6-0.8.
Primary Outcome Measure Information:
Title
Udvalg for Kliniske Undersogelser Side Effect Rating Scale
Description
This is a comprehensive side effect rating scale designed to capture the side effects associated with psychotropic medications in both clinical trials and routine clinical use. Its reliability and validity are well established and it has been used in a variety of clinical trials.Forty-eight items are grouped into four categories: Psychic, Neurological, Autonomic, and Other. Causal relationship to each item is rated as impossible, possible, or probable.
Time Frame
Baseline & Week 8
Secondary Outcome Measure Information:
Title
Clinician Administered Posttraumatic Stress Disorder Scale
Description
Structured interview scale developed to assess the type and severity of Diagnostic and Statistical Manual-III-R posttraumatic stress disorder symptoms with scoring that can be modified for Diagnostic and Statistical Manual-IV criteria. It consists of 17 interviewer-rated items that cover the core symptoms of posttraumatic stress disorder according to the Diagnostic and Statistical Manual criteria. It includes 5 global rating scales that reflect the impact of symptoms on social and occupational functioning, general severity, and recent changes in severity, and the assessor's evaluation of the validity of the patient's report.
Time Frame
Baseline and weeks 1-8
Title
Beck Scale for Suicide Ideation
Description
This is a 21-item, self-report version of the original Scale for Suicide Ideation, a clinician-administered, semi-structured interview (Beck, Kovacs & Weissman, 1979). Response options range from 0-2 (lowest to highest severity) for each item on the scale, with a total scale ranging from 0-38. Items 20 and 21 refer to past suicide attempts and do not contribute to the overall score.
Time Frame
Baseline and weeks 1-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Combat Veterans seeking treatment at the Denver Veterans Affairs Medical Center. Subjects must be between the ages of 18-50 years old, have a diagnosis of Posttraumatic Stress Disorder and assessed with a Clinician Administered Posttraumatic Stress Disorder Scale scoring greater than 15 on the Clinician Administered Posttraumatic Stress Disorder Scale -D. Subjects may have a history mild traumatic brain injury. Subjects must also have a stable medical condition to be considered for the study. Both males and females will be included, and no exclusions will be made for race or ethnicity. Exclusion Criteria: Subjects with substance dependence disorder less than two months prior to study enrollment; history of bipolar, psychotic and/or cognitive disorders; history of moderate-to-severe traumatic brain injury; seizure disorder; sensitivity to lithium or contraindications to lithium treatment; will not be included in this study. Subjects currently enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, will not be included until the subject has completed their participation in the other study. Women, who are pregnant, suspect that they are pregnant, or planning to become pregnant will not be enrolled into the study. Subjects declared incompetent by the Veterans Health Administraytion or other legal authority will not be included for participation in this study. Additionally, research team members involved in the consenting process of the study will not enroll subjects whom appear incompetent to consent. Recruited subjects unable to comprehend the nature of the study, their involvement & possible risks, described to them during the consent/enrollment process, will not be allowed to participate in the study for the respect of the volunteering subject, their safety, & to ensure that volunteering subjects do not experience any coercion to participate in this study.
Facility Information:
Facility Name
Denver Veterans Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

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Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study

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