An observational study in Aggression, sponsored by Hospital Sirio-Libanes. Active, not recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Hospital Sirio-Libanes · Observational
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.
248 studies on the registry are indexed under Aggression; 41 are open to participants now.
This study's enrollment of 4 is below the median of 103 across 21 observational studies indexed under Aggression.
Browse Aggression studies →Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
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Refractory aggressive patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in Aggression Levels
The level of aggression of the patients will be assessed using the overt aggression scale (OAS)
Time frame: 48 months
Change in quality of life
The quality of life will be assessed using the quality of life scale (SF-36).
Time frame: 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.
Time frame: 48 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hospital Sirio-Libanes