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Trial record 3 of 6 for:    testosterone | dementia | Studies with Female Participants
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Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

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ClinicalTrials.gov Identifier: NCT03452878
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
Raquel Chacon Ruiz Martinez, Hospital Sirio-Libanes

Study Description
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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.

Condition or disease Intervention/treatment
Aggression Behavioral: Aggressive behavior

Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients
Actual Study Start Date : August 6, 2014
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Aggression Levels [ Time Frame: 48 months ]
    The level of aggression of the patients will be assessed using the overt aggression scale (OAS)


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 48 months ]
    The quality of life will be assessed using the quality of life scale (SF-36).

  2. Follow-up hormones [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood samples will be collected.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Refractory aggressive patients.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452878


Sponsors and Collaborators
Hospital Sirio-Libanes
Investigators
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Study Director: Luiz Fernando Reis, PhD Hospital Sirio-Libanes
More Information
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Responsible Party: Raquel Chacon Ruiz Martinez, Principal investigator, PhD, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT03452878    
Other Study ID Numbers: 2014-63
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raquel Chacon Ruiz Martinez, Hospital Sirio-Libanes:
Amygdala, neurosurgery, aggressive behavior
Additional relevant MeSH terms:
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Aggression
Aberrant Motor Behavior in Dementia
Behavioral Symptoms