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

Aggression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03452878
• Other study ID #: 2014-63
• Status: Active, not recruiting
• Start date: August 6, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aggression

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aggression Levels	The level of aggression of the patients will be assessed using the overt aggression scale (OAS)	48 months
Secondary	Change in quality of life	The quality of life will be assessed using the quality of life scale (SF-36).	48 months
Secondary	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