Fluoxetine for Subarachnoid Hemorrhage

Phase-Based Estimates
1
Effectiveness
1
Safety
Harborview Medical Center, Seattle, WA
Subarachnoid Hemorrhage+4 More
Fluoxetine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Subarachnoid Hemorrhage

Study Summary

This study is evaluating whether a medication may help prevent depression in individuals who have had a stroke.

See full description

Eligible Conditions

  • Subarachnoid Hemorrhage
  • Hemorrhagic Stroke
  • Stroke
  • Melancholia
  • Depression
  • Depressive Disorder

Treatment Effectiveness

Study Objectives

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.

1 year
Anxiety
Depression
Fatigue
Function
Healthcare Utilization
Sleep Disturbance
Social Support

Trial Safety

Side Effects for

Fluoxetine
Stomach Pains
8%
Weight Loss
8%
Decreased Appetite
4%
Agitated/Restlessness
4%
Silliness/Feeling too happy
4%
Nausea
4%
Dry Mouth
4%
Fatigue
4%
Nightmares
4%
Emotional
4%
Sweating
4%
Suicidal Behavior
4%
Trouble Sleeping
4%
Insomnia
4%
Lit Paper on Fire
4%
Menstrual Cramps
4%
Headache
4%
Numbness
0%
Tingling
0%
Trouble Keeping Balance
0%
Forgetfulness
0%
Heart Pounding/Racing
0%
Weight Gain
0%
Constipation
0%
Visit to ER: Family Conflict
0%
Feeling tense
0%
Light hurts eyes
0%
Visit to ER: Aches
0%
Itchiness
0%
Hair Loss
0%
Room Spinning
0%
Ears ringing
0%
Drowsiness
0%
Dizziness
0%
Blurred/double Vision
0%
Leg Spasms
0%
Delay in Urination
0%
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT00245635) in the Fluoxetine ARM group. Side effects include: Stomach Pains with 8%, Weight Loss with 8%, Decreased Appetite with 4%, Agitated/Restlessness with 4%, Silliness/Feeling too happy with 4%.

Trial Design

2 Treatment Groups

Placebo
Treatment
Placebo group

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.

Treatment
Drug
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
Placebo
Drug
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
M. R. L.
Prof. Michael Robert Levitt, MD
University of Washington

Closest Location

Harborview Medical Center - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients aged 18 years and older will be included. show original
Any patient admitted to the hospital with a subarachnoid hemorrhage caused by a ruptured cerebral aneurysm will be included in the study. show original
Only people who agree to take part in the study will be included. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for subarachnoid hemorrhage?

Add answer

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.

Unverified Answer

What are the signs of subarachnoid hemorrhage?

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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.

Unverified Answer

Can subarachnoid hemorrhage be cured?

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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.

Unverified Answer

What causes subarachnoid hemorrhage?

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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).

Unverified Answer

What is subarachnoid hemorrhage?

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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.

Unverified Answer

How many people get subarachnoid hemorrhage a year in the United States?

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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.

Unverified Answer

Has fluoxetine proven to be more effective than a placebo?

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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.

Unverified Answer

Does subarachnoid hemorrhage run in families?

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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.

Unverified Answer

What are the common side effects of fluoxetine?

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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.

Unverified Answer

How does fluoxetine work?

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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.

Unverified Answer

Does fluoxetine improve quality of life for those with subarachnoid hemorrhage?

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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.

Unverified Answer

Is fluoxetine safe for people?

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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.

Unverified Answer
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