Valproate for Mood Swings and Alcohol Use Following Head Injury
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | September 2008 |
| End Date: | March 2016 |
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.
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, the new 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.
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, the new 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.
Inclusion Criteria:
- Veteran
- history of closed-head traumatic brain injury (TBI) at least one year prior to
enrollment
- symptoms of affective lability such as mood swings, irritability, frustration and
anxiety
- currently using alcohol
Exclusion Criteria:
- history of Axis I bipolar disorder or anxiety disorder prior to the TBI
- skull opened either surgically or traumatically
- history of stroke
- current diagnosis or past history of major psychosis as defined by Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV)
- active liver disease
- evidence of the alcohol amnesic syndrome
- history of seizure disorder other than those caused by ethanol withdrawal
- any type of dementia
- current suicidal/homicidal ideations
- symptomatic thiamine, folate or Vitamin B-12 deficiency
- HIV positive
- any medical conditions that would constitute contraindications to treatment with
divalproex sodium
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