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Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury

This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Surendra Barshikar
168321
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03095066
STU 052018-039
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Inclusion Criteria:

• Participants with traumatic brain injury (TBI)
• Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
• Score of ≥4 on the modified Clinical Global Impression of Severity (mCGI-S) scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
• Participants with a reliable caregiver
Exclusion Criteria:

• Participants with significant symptoms of a major depressive disorder
• Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder
Drug: AVP-786, Drug: Placebo
Neurobehavioral Disinhibition
aggression, agitation, irritability, non-penetrating brain injury, traumatic brain injury, TBI, AVP-786
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