Clinical trial NCT01754883: Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study
Official title: Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Combat Posttraumatic Stess Disorder
Mild Traumatic Brain Injury
Keywords: Posttraumatic Stess Disorder
Lithium
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2012-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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.

Primary outcomes:
measure: Udvalg for Kliniske Undersogelser Side Effect Rating Scale
timeFrame: Baseline & Week 8
Secondary outcomes:
measure: Clinician Administered Posttraumatic Stress Disorder Scale
timeFrame: Baseline and weeks 1-8
measure: Beck Scale for Suicide Ideation
timeFrame: Baseline and weeks 1-8
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Veterans Hospital
state: Colorado
Study officials:
References: