Combat Posttraumatic Stess DisorderPhase 1NCT01754883
Lithium Augmentation for Hyperarousal Symptoms of Post Traumatic Stress Disorder: Pilot Study
A Phase 1 study testing Lithium Carbonate in people with Combat Posttraumatic Stess Disorder and Mild Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Combat Posttraumatic Stess Disorder, Mild Traumatic Brain Injury
- What is being tested?
- Lithium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study
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.
Read the 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.
- Being tested
- Lithium Carbonate
- Keywords
- Posttraumatic Stess Disorder, Lithium
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
Oral Lithium carbonate to target serum levle of 0.6-0.8.
| Study group | Role | What they receive |
|---|---|---|
| Lithium Augmentation | Experimental | Open-label trial - active treatment Receives: Drug: Lithium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline & Week 8
Secondary outcomes (2)
Clinician Administered Posttraumatic Stress Disorder Scale
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.
Measured: Baseline and weeks 1-8
Beck Scale for Suicide Ideation
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.
Measured: Baseline and weeks 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combat Posttraumatic Stess DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754883
- Sponsor's protocol ID
- 10-1170
- Status last verified
- Dec 2012
- First submitted
- 25 Jul 2012
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study
- ClinicalTrials.gov ID
- NCT01754883
- Acronym / sponsor ID
- 10-1170
- Keywords
- Posttraumatic Stess Disorder, Lithium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium Augmentation | Experimental | Drug: Lithium CarbonateOpen-label trial - active treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium CarbonateOral Lithium carbonate to target serum levle of 0.6-0.8. | Drug | Lithium Augmentation |
Primary outcome
Udvalg for Kliniske Undersogelser Side Effect Rating Scale
Time frame: Baseline & Week 8
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.
2 secondary outcomes
Clinician Administered Posttraumatic Stress Disorder Scale
Time frame: Baseline and weeks 1-8
Beck Scale for Suicide Ideation
Time frame: Baseline and weeks 1-8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lithium Carbonate in people with Combat Posttraumatic Stess Disorder and Mild Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Udvalg for Kliniske Undersogelser Side Effect Rating Scale (time frame: Baseline & Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.