JUSTIFICATION AND OBJECTIVES The objective of this study is to evaluate the protective effect
of melatonin on the brain in patients with cerebral infarction. Cerebral infarction is the
death of a small part of the brain that can leave moderate or severe disabilities, such as
paralysis or death. The current treatment does not attempt to stop all the mechanisms of
brain damage that occur with this disease. Melatonin is a substance that probably protects
the brain by regulating cell responses to decrease damage and death of brain cells, in
addition to decreasing and cushioning the secretion of substances that produce greater damage
at the site of the lesion. These effects have been tested in other heart and neurological
diseases in children and adults. However, its effectiveness in this disease in humans has not
been studied, so it will be evaluated in this study. This medication is already approved for
use in humans to improve sleep quality, so its use is safe, and the side effects are mild and
may consist of headache, feeling sleepy during the day, and dizziness. These effects are
discussed in detail in the risks and discomfort section.
PROCEDURES You will receive the usual treatment and studies for the care of cerebral
infarction. In addition, you will be administered melatonin or lactose orally, forming two
groups to evaluate the medication's effectiveness. The group will be assigned in a
sequentially numbered envelope that I will give you containing your medication, which was
previously sorted by someone outside the research, so neither the researcher, nor the doctor,
nor you will know which group you are in. It is essential to mention that lactose tablets
will have no effect.
The treatment consists of one tablet every 12 hours for 7 days and then one tablet every 24
hours at night until completing 83 days. We will perform a head CT scan upon admission, on
day 2, and on day 90. We will also take blood samples for the laboratory (approximately two
teaspoons of blood) on days 0 (upon admission), 5, 30, and 90 to measure substances in the
blood that may be modified by the medication and confirm its protective effect on the brain.
During your hospital stay, your treating physician will evaluate you daily, and we will
perform evaluations on days 3 and 5. Once discharged, the patient will attend monthly medical
follow-up appointments on days 30, 60, and 90 after the infarction.
The blood samples will be stored for later evaluation, within a period of fewer than 3 years,
with the support of the Universidad Michoacana de San Nicolás de Hidalgo and the Centro de
Investigación Biomédica de Michoacán. These samples may be used for future research if you
authorize them.
If you decide to participate, you will take your medication according to the instructions. We
will monitor you during your hospitalization, and you will attend monthly appointments on
days 30, 60, and 90. During these appointments, we will perform clinical evaluations,
administer questionnaires, conduct a CT scan, take blood samples, and provide melatonin or a
placebo. Each appointment will require 60 minutes to perform all the interventions mentioned.
During your illness, you may experience complications specific to cerebral infarction, such
as infections, ulcers, or cerebral hemorrhage, which will be addressed, and only in the case
of a severe infection, you will be withdrawn from the study.
No travel expenses will be provided for follow-up appointments. BENEFITS AT THE END OF THE
STUDY There will be no economic benefits for the patient participating in the study. At the
end of the study, we will have gained more knowledge about the effect of melatonin on brain
protection for patients with embolism, in order to offer another alternative in treatment
that can decrease the complications caused by this disease. The administration of the
medication is experimental and we hope that by receiving it, the patient may experience
clinical improvement and a decrease in disability, although it is possible that it may not
have any effect on the patient.
RISKS AND DISCOMFORT Melatonin has been shown to be a safe medication and is authorized for
use in children and adults for the treatment of insomnia and disorders caused by changes in
time zone due to travel or working night shifts. This study will evaluate the effectiveness
of melatonin in the clinical development of the disease and its complications. By taking this
medication, you may experience the following in order of frequency: drowsiness (28%), fatigue
(25%), mood changes (16.7%), headache (13.3%), vomiting (13.3%), and hives (5%). If any of
these symptoms occur, please contact us to determine the appropriate course of action,
whether it be monitoring, treatment, hospitalization, or discontinuation of melatonin. In
rare cases, you may experience increased activity, restlessness, decreased temperature, skin
rash, insomnia, burping, tearing, fatigue, feeling heavy, nausea, decreased appetite,
tiredness, or nighttime urinary incontinence. Again, if any of these symptoms occur, please
contact us to determine the appropriate course of action.
The blood sample collection may cause slight pain from the needle and bruising at the
puncture site. If these symptoms are not tolerable, please contact us at the phone numbers
provided or go to the hospital's emergency department. You will also have an open appointment
for emergency services when needed.
RESULTS INFORMATION AND TREATMENT ALTERNATIVES The complete results of this study will be
available at the end of 2025 and will be sent to your registered email or phone number. You
will be informed about the type of treatment received the results of your studies, as well as
the results of the project. If a new treatment that improves your medical condition is
discovered during the study, you will be informed immediately.
If any unforeseen events occur directly caused by the research, you will be treated at the
IMSS or ISSSTE, depending on the institute you are registered with.
PARTICIPATION OR WITHDRAWAL Your participation is completely voluntary, and you may ask any
questions you deem necessary at any time should you have any doubts. You may make the
decision that you consider best, without this affecting your relationship with the IMSS or
ISSSTE Institute (according to your registration). If you choose to participate in the study,
you may leave the study at any time without affecting your care or relationship with the
Institute or your doctor, and you may continue with your usual care and treatment.
If you decide to participate, you will have a contact person to stay in communication with
the researcher whenever you deem it necessary.
If you choose not to participate, your relationship and care at the institute or with your
doctor will not be affected, and you may continue with your usual care and treatment.