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

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.

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.