Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.

Alcoholism Clinical Trial

Official title:

A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01326663
• Other study ID #: PT075168
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2011
• Last updated: September 6, 2012
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Denver Research Institute
• Contact: Brandon Schmidt, MA
• Phone: 720-854-4200
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Irritable Mood
• TBI
• Veterans

Intervention

Drug:
• Medication Trial

Locations

Country	Name	City	State
United States	Denver Veteran's Affairs Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Paul Saenger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Study weeks 1-10	No
Secondary	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).	Study weeks 1-10	No