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

NCT01326663 | Unknown

• 1 other identifier: PT075168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Veterans; TBI; Alcoholism; Irritable Mood

Keywords

Veterans; TBI; Alcoholism; Mood

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Reduced Alcohol Use

  Study weeks 1-10

Study Arms (2)

divalproex sodium

ACTIVE COMPARATOR

Drug: Medication Trial

sugar pill

PLACEBO COMPARATOR

Drug: Medication Trial

Interventions

Medication Trial DRUG

divalproex sodium; sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a history of remote (≥ 1 year prior to study enrollment) non-penetrating TBI
• currently using alcohol
• symptoms of affective lability: mood swings, irritability, frustration

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Saenger: lead

Study Sites (1)

Denver Veteran's Affairs Medical Center

Denver, Colorado, 80220, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Brandon Schmidt, MA

CONTACT

720-854-4200

Thomas Beresford, MD

CONTACT

303-315-9130

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 31, 2011
• Study Start: October 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)