Beresford 2011.

Trial name or title	A double‐blind trial of divalproex sodium for affective lability and alcohol use following traumatic brain injury (TBI)
Methods	Randomised placebo‐controlled double‐blind trial
Participants	Inclusion criteria: 18 to 65 years old; both genders; history of remote (one year before study enrolment) non‐penetrating TBI; currently using alcohol; symptoms of affective lability: mood swings, irritability, frustration Exclusion criteria: history of bipolar disorder or anxiety disorder before any head injury; history of head injury in which the cranium was opened traumatically or surgically; history of stroke; history of seizure disorder other than those caused by ethanol withdrawal; evidence of active liver disease; current diagnosis or past history of major psychosis, alcohol amnesic syndrome, dementia; current suicidal/homicidal ideations; medical conditions that would constitute contraindications to treatment with divalproex sodium; taking medications known to affect metabolism of divalproex sodium
Interventions	(1) Valproic acid; (2) placebo Duration: 14 weeks. Country of origin: USA
Outcomes	Primary outcomes: affective lability (presence or extent of symptoms yielded by the Neurobehavioral Rating Scale‐Revised as well as by the Agitated Behavior Scale Secondary outcomes: alcohol use measured using the TLFB for Drugs and Alcohol method (Sobell 1979)
Starting date	2011
Contact information	Brandon Schmidt, MA, +172 085 44200; Thomas Beresford, MD, +130 331 59130, Denver Research Institute, Veterans Affairs Medical Center, Denver, Colorado, United States 80220
Notes