N/A
N=50
Valproate for Mood Swings and Alcohol Use Following Head Injury
Traumatic Brain Injury (TBI) · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01760785 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Severity of Affective Lability Based on Shortened Agitated Behavior Scale — 9.22; 9.39 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- divalproex sodium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Affective Lability Based on Shortened Agitated Behavior Scale |
9.22; 9.39 | — |
| SECONDARY Frequency of Alcohol Use |
0; 0 | — |
Summary
Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective lability following TBI. Observed clinically, the symptoms of poorly regulated affective expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for example. Instead, both symptoms and course appear more characteristic of the sustained affect lability often observed following TBI. This observation suggests that TBI survivors represent a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate both TBI-related affect lability and also heavy ethanol use by treating the condition that is contextually related to excessive alcohol use.
Based on this concept of consequently treating AA/D through the management of post-TBI affective lability, this study was conducted observing the efficacy of divalproex sodium on the severity of affective lability and AA/D in persons suffering from a moderate TBI. Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance abuse problems. This drug has also shown positive results as an alternate medication to benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the progression of withdrawal symptoms in patients.
Eligibility Criteria
Inclusion Criteria
- Veteran
- history of closed-head traumatic brain injury (TBI) at least one year prior to enrollment
- symptoms of affective lability such as mood swings, irritability, frustration and anxiety
- currently using alcohol
Exclusion Criteria
- history of Axis I bipolar disorder or anxiety disorder prior to the TBI
- skull opened either surgically or traumatically
- history of stroke
- current diagnosis or past history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- active liver disease
- evidence of the alcohol amnesic syndrome
- history of seizure disorder other than those caused by ethanol withdrawal
- any type of dementia
- current suicidal/homicidal ideations
- symptomatic thiamine, folate or Vitamin B-12 deficiency
- HIV positive
- any medical conditions that would constitute contraindications to treatment with divalproex sodium
Data sourced from ClinicalTrials.gov (NCT01760785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.