AggressionNCT03452878
Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients
An observational study of Aggression, run by Hospital Sirio-Libanes.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggression
- What is being tested?
- Aggressive behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2014to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Refractory aggressive patients.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Aggressive behavior
- Keywords
- Amygdala, neurosurgery, aggressive behavior
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive behaviorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aggressive behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aggression Levels
The level of aggression of the patients will be assessed using the overt aggression scale (OAS)
Measured: 48 months
Secondary outcomes (2)
Change in quality of life
The quality of life will be assessed using the quality of life scale (SF-36).
Measured: 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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start6 Aug 2014
- Primary completion30 Jun 2018
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Chacon Ruiz Martinez, Hospital Sirio-Libanes
- Investigators
- Luiz Fernando Reis, PhD, Study director, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452878
- Sponsor's protocol ID
- 2014-63
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2017
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients
- ClinicalTrials.gov ID
- NCT03452878
- Acronym / sponsor ID
- 2014-63
- Conditions
- Aggression
- Keywords
- Amygdala, neurosurgery, aggressive behavior
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 6 Aug 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aggressive refractory patient | – | Behavioral: Aggressive behaviorA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Refractory aggressive patients.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive behaviorAggressive 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. | Behavioural | Aggressive refractory patient |
Primary outcome
Change in Aggression Levels
Time frame: 48 months
The level of aggression of the patients will be assessed using the overt aggression scale (OAS)
2 secondary outcomes
Change in quality of life
Time frame: 48 months
Follow-up hormones
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Fernando Reis, PhD study director
Hospital Sirio-Libanes
Questions about this trial
What is this clinical trial studying?
An observational study of Aggression, run by Hospital Sirio-Libanes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aggression Levels (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.