Fluoxetine Doesn’t Reduce Depression During Stroke Recovery

(Reuters Health) – Adults recovering from a stroke don’t appear to have a lower risk of clinically significant depression symptoms when they’re prescribed fluoxetine hydrochloride during their recovery, a clinical trial suggests.

Researchers randomly assigned adult stroke patients (mean age 64.3 years) to take fluoxetine hydrochloride 20mg (n=614) or placebo (n=617) daily for six months, with mental health assessments at baseline and again at 4, 12, and 26 weeks. At baseline, similar proportions of the intervention group (18.9%) and the placebo group (18.5%) had scores of 9 or higher on the 9-item Patient Health Questionnaire (PHQ-9), indicating clinically significant symptoms of depression.

Overall, during follow-up, similar proportions of patients on fluoxetine (20.2%) and placebo (21.1%) had PHQ-9 scores indicating clinically significant symptoms of depression, the study found.

Similar proportions of patients with baseline PHQ-9 scores below 9 had developed scores above 9 and had clinically significant symptoms of depression in the fluoxetine (13.0%) and placebo (14.8%) groups at 26 weeks, the study also found.

“Depressive symptoms are common after stroke, but for a large proportion of patients these symptoms are short-lived and resolve within a few weeks,” said lead study author Osvaldo Almeida, a professor of geriatric psychiatry at the University of Western Australia in Perth.

General supportive measures and early rehabilitation may override any potential benefits associated with the use of fluoxetine, Almeida said by email. In addition, it’s possible that post-stroke depression has a different physiological origin than major depressive disorder, making fluoxetine less effective after stroke, Almeida added.

“Routine use of fluoxetine cannot be recommended for the prevention or treatment of post-stroke depression,” Almeida said.

The study did find slightly more patients in the placebo group (7.0%) than those given fluoxetine (4.3%) reported a clinician diagnosis of depression during the study. However, fluoxetine didn’t influence the proportion of patients prescribed antidepressants or receiving nonpharmacologic treatments for depression.

One limitation of the study is that it included stable patients with only mild to moderate deficits, and it’s possible the results would look different for stroke patients with more severe disabilities, the study team notes in JAMA Neurology.

Another limitation is that the PHQ-9, which is validated for assessing depression after a stroke, is not a standard tool for assessing major depressive disorder, the authors point out. The study also may have failed to identify small but significant differences between groups because only 63.3% of the participants were alive and had completed all follow-up assessments by week 26.

However, many clinicians don’t use fluoxetine for post-stroke depression due to previous studies that also found limited evidence of its benefits in this population, said Dr. Sean Dukelow, section chief of physical medicine and rehabilitation in the Department of Clinical Neurosciences at the University of Calgary in Canada and coauthor of an editorial accompanying the study.

“Over the years we have migrated to using citalopram or escitalopram as these have better evidence and are generally well tolerated after stroke,” Dr. Dukelow said by email. “With the number of options available, I do not foresee clinicians prescribing much fluoxetine specifically for post-stroke depression going forward.”

SOURCE: https://bit.ly/3yoLuqK and https://bit.ly/37cQF0Z JAMA Neurology, online August 2, 2021.

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