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

NCT01754883 | Withdrawn Phase 1

• 1 other identifier: 10-1170
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Combat Posttraumatic Stess Disorder; Mild Traumatic Brain Injury

Keywords

Posttraumatic Stess Disorder; Lithium

Outcome Measures

Primary Outcomes (1)

• Udvalg for Kliniske Undersogelser Side Effect Rating Scale

  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.

  Baseline & Week 8

Secondary Outcomes (2)

• Clinician Administered Posttraumatic Stress Disorder Scale

  Baseline and weeks 1-8

• Beck Scale for Suicide Ideation

  Baseline and weeks 1-8

Study Arms (1)

Lithium Augmentation

EXPERIMENTAL

Open-label trial - active treatment

Drug: Lithium Carbonate

Interventions

Lithium Carbonate DRUG

Oral Lithium carbonate to target serum levle of 0.6-0.8.

Lithium Augmentation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

Denver Veterans Hospital

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 7, 2016

Record last verified: 2012-12

Locations

US (1)