VeteransNCT01326663
Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.
A study testing Medication Trial in people with Veterans and TBI, run by Paul Saenger at 1 site in United States.
Trial summary
Despite the body's natural healing during the first year after a head injury, many veterans who have suffered even mild brain injuries find themselves easily upset or fearful as they go about their daily lives. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Veterans, TBI, Alcoholism
- What is being tested?
- Medication Trial
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of remote (≥ 1 year prior to study enrollment) non-penetrating TBI
- currently using alcohol
- symptoms of affective lability: mood swings, irritability, frustration
Who cannot join
- a history of bipolar disorder or anxiety disorder prior to any head injury
- a history of head injury in which the cranium was opened either traumatically or surgically
- a history of stroke
- a history of seizure disorder other than those caused by ethanol withdrawal
- evidence of active liver disease
- current diagnosis or past history of major psychosis, the alcohol amnesic syndrome, or any type of dementia
Show all 9Show fewer
- current suicidal/homicidal ideations
- any medical conditions that would constitute contraindications to treatment with divalproex sodium
- currently taking any medications that are known to affect the metabolism of divalproex sodium
Trial locations and contacts
1 site in 1 country.
Brandon Schmidt, MA contact
Thomas Beresford, MD contact
United States1 site, 1 recruiting
- Recruiting
Denver Veteran's Affairs Medical Center
Denver, Colorado, 80220
Brandon Schmidt, MA, 720-854-4200
About this study
Official title: A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury
Despite the body's natural healing during the first year after a head injury, many veterans who have suffered even mild brain injuries find themselves easily upset or fearful as they go about their daily lives. While these reactions to the world around them were easily managed before the head injury, they now occur with little or no interruption and are exceedingly difficult to manage. Such reactions include a sense of always being upset or fearful that often makes it difficult to get along with family members, friends, coworkers, and employers. This may lead to broken marriages, unemployment, and even homelessness.
Some people with head injuries try to manage their unmanageable moods by drinking alcohol because it can create a sense of calm. However, alcohol's actions are short in duration. Most find that they have to drink more and more for a similar calming effect, and they soon become dependent on alcohol. This makes working and being part of their families even more difficult.
Read more
To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood problems in people without head injury. We gave valproate to head injured persons with mood problems in a "non-blinded" study where both the doctor and the patient knew that the medicine was valproate and both were optimistic that it would work. In a small sample of eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or drank much less than before. However, this might have been because both the doctor and patient were hopeful that the medication would make the patient feel better or because the medicine actually worked.
The only way to know for sure if the medicine works is to perform a study in which people receive either valproate or a sugar pill while neither they nor their doctor know which one they are taking. This is called a double blind study, as proposed here, and will involve nearly three times as many head injured persons as the first study.
If it is successful, this study will show that valproate treatment helps head injured people manage their moods and allows them to return to families, friends, and work. It will also show that they drink alcohol less or not at all, improving their health even further. Then doctors will know that they can use this medicine for large numbers of people who suffer from head injury and help them to lead normal lives. If the outcome of the study shows that the medicine works well, doctors can then use this medicine to treat people with head injury immediately after the study results are published.
- Conditions
- Veterans, TBI, Alcoholism, Irritable Mood
- Being tested
- Medication Trial
- Keywords
- Veterans, TBI, Alcoholism, Mood
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication TrialDrug
| Study group | Role | What they receive |
|---|---|---|
| divalproex sodium | Active comparator | Not described Receives: Drug: Medication Trial |
| sugar pill | Placebo comparator | Not described Receives: Drug: Medication Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Affective Lability
The primary analysis addresses our primary hypothesis that treatment with divalproex sodium will lessen affective lability significantly (p<0.05) as compared to placebo. We will characterize affective lability using discrete variables of presence or extent of symptoms yielded by the Neurobehavioral Rating Scale-Revised (Levin et al., 1990) as well as eight target items from the Agitated Behavior Scale (Bogner et al., 2000). Average intensity and duration of affective lability will be compared between groups.
Measured: Study weeks 1-10
Secondary outcomes (1)
Reduced Alcohol Use
The secondary analysis first addresses our secondary hypothesis that treatment with divalproex sodium will lessen quantity and frequency of ethanol use significantly (p<0.05) as compared to placebo in a sample of TBI subjects. We will characterize drinking using the Time Line Follow-Back for Drugs and Alcohol method, developed by Sobell et al (Sobell et al., 1979).
Measured: Study weeks 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startOct 2009
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeteransStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Saenger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Saenger, Denver Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326663
- Sponsor's protocol ID
- PT075168
- Status last verified
- Sep 2012
- First submitted
- 29 Mar 2011
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01326663
- Acronym / sponsor ID
- PT075168
- Conditions
- Veterans, TBI, Alcoholism, Irritable Mood
- Keywords
- Veterans, TBI, Alcoholism, Mood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Paul SaengerUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 31 Mar 2011 (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.
Despite the body's natural healing during the first year after a head injury, many veterans who have suffered even mild brain injuries find themselves easily upset or fearful as they go about their daily lives. While these reactions to the world around them were easily managed before the head injury, they now occur with little or no interruption and are exceedingly difficult to manage. Such reactions include a sense of always being upset or fearful that often makes it difficult to get along with family members, friends, coworkers, and employers. This may lead to broken marriages, unemployment, and even homelessness.
Some people with head injuries try to manage their unmanageable moods by drinking alcohol because it can create a sense of calm. However, alcohol's actions are short in duration. Most find that they have to drink more and more for a similar calming effect, and they soon become dependent on alcohol. This makes working and being part of their families even more difficult.
To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood problems in people without head injury. We gave valproate to head injured persons with mood problems in a "non-blinded" study where both the doctor and the patient knew that the medicine was valproate and both were optimistic that it would work. In a small sample of eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or drank much less than before. However, this might have been because both the doctor and patient were hopeful that the medication would make the patient feel better or because the medicine actually worked.
The only way to know for sure if the medicine works is to perform a study in which people receive either valproate or a sugar pill while neither they nor their doctor know which one they are taking. This is called a double blind study, as proposed here, and will involve nearly three times as many head injured persons as the first study.
If it is successful, this study will show that valproate treatment helps head injured people manage their moods and allows them to return to families, friends, and work. It will also show that they drink alcohol less or not at all, improving their health even further. Then doctors will know that they can use this medicine for large numbers of people who suffer from head injury and help them to lead normal lives. If the outcome of the study shows that the medicine works well, doctors can then use this medicine to treat people with head injury immediately after the study results are published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| divalproex sodium | Active comparator | Drug: Medication Trial |
| sugar pill | Placebo comparator | Drug: Medication Trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a history of remote (≥ 1 year prior to study enrollment) non-penetrating TBI
- currently using alcohol
- symptoms of affective lability: mood swings, irritability, frustration
Key exclusion criteria (9 listed)
- a history of bipolar disorder or anxiety disorder prior to any head injury
- a history of head injury in which the cranium was opened either traumatically or surgically
- a history of stroke
- a history of seizure disorder other than those caused by ethanol withdrawal
- evidence of active liver disease
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 |
|---|---|---|
| Medication Trial | Drug | divalproex sodium, sugar pill |
Primary outcome
Reduced Affective Lability
Time frame: Study weeks 1-10
The primary analysis addresses our primary hypothesis that treatment with divalproex sodium will lessen affective lability significantly (p<0.05) as compared to placebo. We will characterize affective lability using discrete variables of presence or extent of symptoms yielded by the Neurobehavioral Rating Scale-Revised (Levin et al., 1990) as well as eight target items from the Agitated Behavior Scale (Bogner et al., 2000). Average intensity and duration of affective lability will be compared between groups.
1 secondary outcome
Reduced Alcohol Use
Time frame: Study weeks 1-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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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.
Brandon Schmidt, MA contact
Thomas Beresford, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Trial in people with Veterans and TBI, run by Paul Saenger 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Sep 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brandon Schmidt, MA (720-854-4200), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced Affective Lability (time frame: Study weeks 1-10). 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 Sep 2012.