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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Denver Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Paul Saenger, Denver Research Institute
ClinicalTrials.gov Identifier:
NCT01326663
First received: March 29, 2011
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Veterans
TBI
Alcoholism
Irritable Mood
Drug: Medication Trial

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Denver Research Institute:

Primary Outcome Measures:
  • Reduced Affective Lability [ Time Frame: Study weeks 1-10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Reduced Alcohol Use [ Time Frame: Study weeks 1-10 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: divalproex sodium Drug: Medication Trial
Placebo Comparator: sugar pill Drug: Medication Trial

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326663

Contacts
Contact: Brandon Schmidt, MA 720-854-4200
Contact: Thomas Beresford, MD 303-315-9130

Locations
United States, Colorado
Denver Veteran's Affairs Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Brandon Schmidt, MA    720-854-4200      
Sponsors and Collaborators
Paul Saenger
  More Information

No publications provided

Responsible Party: Paul Saenger, Executive Director, Denver Research Institute
ClinicalTrials.gov Identifier: NCT01326663     History of Changes
Other Study ID Numbers: PT075168
Study First Received: March 29, 2011
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Denver Research Institute:
Veterans
TBI
Alcoholism
Mood

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014