Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.
Divalproex Sodium for Mood Swings and Alcohol Use Following Head 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, 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.
Inclusion Criteria:

 -  a history of remote (≥ 1 year prior to study enrollment) non-penetrating TBI

 -  currently using alcohol

 -  symptoms of affective lability: mood swings, irritability, frustration

 Exclusion Criteria:

 -  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

 -  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