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

Withdrawn before enrolling · Phase 1

Conditions studied: Combat Posttraumatic Stess Disorder, Mild Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01754883

Run by

VA Eastern Colorado Health Care System

People needed

0

Starts

2011-01-01

Expected to finish

2014-01-01

Last updated by the study team

2016-01-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Denver Veterans Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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