Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study
Combat Posttraumatic Stess Disorder
Mild Traumatic Brain Injury
Drug: Lithium Carbonate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study|
- Udvalg for Kliniske Undersogelser Side Effect Rating Scale [ Time Frame: Baseline & Week 8 ] [ Designated as safety issue: No ]This is a comprehensive side effect rating scale designed to capture the side effects associated with psychotropic medications in both clinical trials and routine clinical use. Its reliability and validity are well established and it has been used in a variety of clinical trials.Forty-eight items are grouped into four categories: Psychic, Neurological, Autonomic, and Other. Causal relationship to each item is rated as impossible, possible, or probable.
- Clinician Administered Posttraumatic Stress Disorder Scale [ Time Frame: Baseline and weeks 1-8 ] [ Designated as safety issue: No ]Structured interview scale developed to assess the type and severity of Diagnostic and Statistical Manual-III-R posttraumatic stress disorder symptoms with scoring that can be modified for Diagnostic and Statistical Manual-IV criteria. It consists of 17 interviewer-rated items that cover the core symptoms of posttraumatic stress disorder according to the Diagnostic and Statistical Manual criteria. It includes 5 global rating scales that reflect the impact of symptoms on social and occupational functioning, general severity, and recent changes in severity, and the assessor's evaluation of the validity of the patient's report.
- Beck Scale for Suicide Ideation [ Time Frame: Baseline and weeks 1-8 ] [ Designated as safety issue: Yes ]This is a 21-item, self-report version of the original Scale for Suicide Ideation, a clinician-administered, semi-structured interview (Beck, Kovacs & Weissman, 1979). Response options range from 0-2 (lowest to highest severity) for each item on the scale, with a total scale ranging from 0-38. Items 20 and 21 refer to past suicide attempts and do not contribute to the overall score.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Lithium Augmentation
Open-label trial - active treatment
Drug: Lithium Carbonate
Oral Lithium carbonate to target serum levle of 0.6-0.8.
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.
Establish the safety and tolerability of lithium augmentation of psychopharmacological treatment as usual for combat veterans with posttraumatic stress disorder.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754883
|United States, Colorado|
|Denver Veterans Hospital|
|Denver, Colorado, United States, 80220|