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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by VA Eastern Colorado Health Care System
Sponsor:
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01754883
First received: July 25, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Combat Posttraumatic Stess Disorder
Mild Traumatic Brain Injury
Drug: Lithium Carbonate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Udvalg for Kliniske Undersogelser Side Effect Rating Scale [ Time Frame: Baseline & Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and weeks 1-8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and weeks 1-8 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lithium Augmentation
Open-label trial - active treatment
Drug: Lithium Carbonate
Oral Lithium carbonate to target serum levle of 0.6-0.8.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754883

Locations
United States, Colorado
Denver Veterans Hospital Recruiting
Denver, Colorado, United States, 80220
Contact: Latoya Conner, BS    303-399-8020 ext 5616    latoya.conner@va.gov   
Contact: Hal S Wortzel, MD    303-399-8020 ext 5644    hal.wortzel@va.gov   
Principal Investigator: Hal S Wortzel, MD         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
  More Information

No publications provided

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01754883     History of Changes
Other Study ID Numbers: 10-1170
Study First Received: July 25, 2012
Last Updated: December 18, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: General Accountability Office
United States: Veterans Affairs Research and Development
United States: Colorado Multiple Institution Review Board

Keywords provided by VA Eastern Colorado Health Care System:
Posttraumatic Stess Disorder
Lithium

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Pathologic Processes
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014