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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-06

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Aggression Management Care Bundle

NCT06661824

Aggression

COMPLETED NA

Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients

NCT02841345

Schizophrenia Bipolar Disorder

UNKNOWN NA

Can Cognitive Training Decrease Reactive Aggression?

NCT03623477

Schizophrenia Cognitive Deficits Impulsive Aggression +2 more

COMPLETED NA

Aggressive Acts Among Patients With Schizophrenia

NCT00172497

Schizophrenia

SUSPENDED

Clozapine IM and Aggression in Schizophrenic Patients

NCT00189995

Schizophrenia

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aggression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Aggressive behavior

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No