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

Mild Traumatic Brain Injury Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Combat Posttraumatic Stess Disorder
• Mild Traumatic Brain Injury
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT01754883
• Study type: Interventional
• Source: VA Eastern Colorado Health Care System
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2011
• Completion date: January 2014