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

Information source: VA Eastern Colorado Health Care System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Combat Posttraumatic Stess Disorder; Mild Traumatic Brain Injury

Intervention: Lithium Carbonate (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: VA Eastern Colorado Health Care System


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Udvalg for Kliniske Undersogelser Side Effect Rating Scale

Secondary outcome:

Clinician Administered Posttraumatic Stress Disorder Scale

Beck Scale for Suicide Ideation

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.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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.

Locations and Contacts

Denver Veterans Hospital, Denver, Colorado 80220, United States; Recruiting
Latoya Conner, BS, Phone: 303-399-8020, Ext: 5616, Email: latoya.conner@va.gov
Hal S Wortzel, MD, Phone: 303-399-8020, Ext: 5644, Email: hal.wortzel@va.gov
Hal S Wortzel, MD, Principal Investigator
Additional Information

Starting date: January 2011
Last updated: December 18, 2012

Page last updated: August 23, 2015

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