This trial is evaluating whether Fluoxetine will improve 1 primary outcome and 6 secondary outcomes in patients with Subarachnoid Hemorrhage. Measurement will happen over the course of 1 year.
This trial requires 224 total participants across 2 different treatment groups
This trial involves 2 different treatments. Fluoxetine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.
Results from a recent paper of this study showed the most commonly used medications in patients treated for SAH were analgesics (30%), thrombolytics (22%), and antispasmodics (21%). Results from a recent paper also showed that ACE inhibitors, beta-adrenergic agonists, and beta-adrenergic antagonists are not commonly used as a first line treatment for SAH. A comprehensive list of therapies can be found in Table 1.
Symptoms and signs of spontaneous subarachnoid hemorrhage have not been standardized, and there is no single set of criteria that defines them. The signs and symptoms of subarachnoid hemorrhage range from acute onset of headache, and vomiting, photophobia, diplopia, and dyspnea or respiratory distress to mental confusion, focal neurologic signs, and/or a drowsy, comatose, or flat alert (unresponsive) patient with signs of brain herniation to a patient with seizures and focal neurological deficits. The differential diagnosis for such patients includes subdural hematoma, cerebral contusions, cerebral edema, cerebral ischemia, diffuse axonal injury, and diffuse brain injury.
The treatment modalities for patients with an ASA grade 3-4 SAH need to be explored in a multiinstitutional, randomized, controlled study comparing outcomes in this high-risk population.
In SAH patients, the most important factors for predicting the occurrence of subdural hematomas on admission were hemorrhagic SDH volume, hemoglobin level, and neurological status at admission. All patients who developed SDHs had a history of a fall or concussion, but neither the history of a brain disorder or previous head trauma predicts SDH occurrence (p=0.067).
SAH defines two broad categories of neurosurgical emergencies. The first category is those patients with a vasospasm who do not experience a delay in their recovery and who return to full work function in a few days. The third category entails those who do not have a vasospasm who do not recover normal function and who may be hospitalized for lengthy periods of time. The treatment of SAH should take into account the factors of age, severity, and comorbidities.
About 26,000 will have a single SAH each year, but about 13,000 will have three or more events. Over 10% of SAHs occur in patients with pre-existing co-morbid psychiatric illness.
No difference was found between fluoxetine (Prozac) and a placebo in the reduction in acute or total number of days of headache after subarachnoid hemorrhage. There were no differences between the two in pain, agitation, visual symptoms, or quality of life. Further research is needed to clarify the role of the serotonin mechanism in the acute phase after acute subarachnoid hemorrhage.
In a recent study, findings show positive linkage between two familial AD and an SAH. In a recent study, findings support the hypothesis that a genetic factor is involved in the pathophysiology of both SAH and familial AD.
The side effects of fluoxetine were mainly related to the antidepressant drugs (such as duloxetine) that are commonly used for panic disorder or OCD. These side effects can be easily monitored with the use of specific measures.
Fluoxetine may be used as a adjuvant to standard first-line anticonvulsant therapy in epilepsy surgery, even in the absence of preoperative epilepsy. Patients with prior partial seizures seem to have a higher chance of seizure recurrence.
Given that no significant differences were found in the time to reach the target threshold, it is possible that all participants, regardless of group, were enrolled at a threshold near the time of the study, at which neither treatment group is statistically significantly different from the control. Although a lower threshold was chosen, it is unlikely to be so significantly low as is generally assumed.
A review and summary of all published data suggest that fluoxetine does not have a major adverse effects in people treated for anxiety or depression if they adequately follow doctors' instructions.