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

NCT03452878 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Aggression

Interventions

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.

Sponsors & Collaborators

  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Luiz Fernando Reis, PhD · Hospital Sirio-Libanes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-06
Primary Completion
2018-06-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452878 on ClinicalTrials.gov