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

Active, not recruiting

• Conditions: Aggression
• Interventions: Behavioral: Aggressive behavior

• Registration Number: NCT03452878
• Lead Sponsor: Hospital Sirio-Libanes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-06
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Primary Completion: 2018-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aggressive refractory patient	Aggressive behavior	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.

Primary Outcome Measures

Name	Time	Method
Change in Aggression Levels	48 months	The level of aggression of the patients will be assessed using the overt aggression scale (OAS)

Secondary Outcome Measures

Name	Time	Method
Follow-up hormones	48 months	The thyroid-stimulating hormone, T4, T3, luteinizing hormone, testosterone, progesterone, prolactin, estradiol, cortisol and sex hormone-binding will be evaluated. The data will be evaluate comparing to the normal range and also will be correlate with the overt aggression scale.
Change in quality of life	48 months	The quality of life will be assessed using the quality of life scale (SF-36).