Recruiting

Divalproex Sodium

Sponsor:

Paul Saenger

Code:

NCT01326663

Conditions

Veterans

TBI

Alcoholism

Irritable Mood

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Medication Trial

Study Details

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

Study ID

NCT01326663

Start date

Oct, 2009

Status verified date

Sep, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: divalproex sodium

placebo comparator: sugar pill

Interventions

Medication Trial

Primary outcome measure

  • Reduced Affective Lability [ Time Frame: Study weeks 1-10 ]

Central Contacts and Locations

Central contacts

Brandon Schmidt, MA

720-854-4200

Thomas Beresford, MD

303-315-9130

Locations

Denver Veteran's Affairs Medical Center

Recruiting

Denver, Colorado, United States, 80220

Contacts

Brandon Schmidt, MA

720-854-4200

More Information

Sponsor

Paul Saenger

Last update posted

Sep 7, 2012

Last verified

Sep, 2012

Keywords

  • Veterans
  • TBI
  • Alcoholism
  • Mood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul Saenger on 2012-09-07.