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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aggression
• Intervention / Treatment: Behavioral: Aggressive behavior

• Study Type: Observational
• Enrollment (Actual): 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Refractory aggressive patients.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aggressive refractory patient; 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.	Behavioral: Aggressive behavior; Aggressive Behavior Scale, Quality of Life (SF-36) and Agitated Behavior Scale, measurement of thyroid-stimulating hormone (TSH), T4, T3, Cortisol, Luteinizing Hormone (LH), Estradiol, Prolactin, Progesterone, testosterone, and sex hormone-binding globulin (SHBG) and Resonance Magnetic Imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aggression Levels	The level of aggression of the patients will be assessed using the overt aggression scale (OAS)	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	The quality of life will be assessed using the quality of life scale (SF-36).	48 months
Follow-up hormones	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.	48 months

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Investigators: Study Director: Luiz Fernando Reis, PhD, Hospital Sirio-Libanes

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2014
• Primary Completion (Actual): June 30, 2018
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Amygdala, neurosurgery, aggressive behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: 2014-63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No