Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

Hospital Sirio-Libanes

Status: Active, not recruiting

Conditions: Aggression

Treatments: Behavioral: Aggressive behavior

Study type: Observational

Funder types: Other

Identifiers

NCT03452878

2014-63

Details and patient eligibility

About

Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory aggression (Adler et al., 2015) defined by extreme levels of aggression after the use of Risperidone or Aripiprazole ou combination of others psychoactive drugs.

Exclusion criteria

• Patients with anatomical alterations that may disrupt the surgery, infections or non-controlled diseases, treatment with other experimental drugs, pregnant women or during lactation, psychological or sociological conditions that will not permit the patient to be accompanied by the medical staff.

Trial design

4 participants in 1 patient group

Aggressive refractory patient

Description:

A pre defined group of individuals will be included in the study. This group is considered aggressive refractory patient and will be submitted to the bilateral amygdalotomy surgery.

Treatment:

Behavioral: Aggressive behavior