Depression is the result of having NO PROTOCOLS LEADING TO 100% RECOVERY. Fix that and you wouldn't have to treat this secondary problem.
Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery
The AFFINITY Randomized Clinical Trial
Key Points
Question Does the daily use of 20 mg of fluoxetine hydrochloride for the management of adults with a recent stroke decrease the prevalence of clinically significant symptoms of depression over 26 weeks?
Findings In this randomized, double-blind, placebo-controlled clinical trial of 1221 patients, the routine daily use of 20 mg of fluoxetine for 26 weeks did not reduce the proportion of those with a recent stroke who developed clinically significant symptoms of depression compared with placebo (20% vs 21%).
Meaning Patients with recent stroke should not be treated routinely with 20 mg daily of fluoxetine to prevent or treat clinically significant symptoms of depression during the first 6 months after the stroke.
Importance One in 3 adults experiences clinically significant symptoms of depression during the first year after a stroke, but evidence to support the use of antidepressants in this population remains scant.
Objective To investigate whether daily treatment with 20 mg of fluoxetine hydrochloride reduces the proportion of people affected by clinically significant symptoms of depression after stroke.
Design, Setting, and Participants In this secondary analysis of the Assessment of Fluoxetine in Stroke Recovery parallel-group, randomized (1:1 assignment), double-blind, placebo-controlled clinical trial, 1221 participants in Australia, New Zealand, and Vietnam were recruited between January 11, 2013, and June 30, 2019, and were followed up for 6 months. Adults aged 18 years or older were recruited 2 to 15 days after experiencing a stroke associated with modified Rankin Scale score of 1 or higher.
Interventions Fluoxetine hydrochloride, 20 mg, or matched placebo daily for 26 weeks.
Main Outcomes and Measures A 9-item Patient Health Questionnaire (PHQ-9) score of 9 or lower was a prespecified secondary outcome of the trial. Assessments were completed at baseline and at 4, 12, and 26 weeks. Other outcomes of interest included participant-reported clinician diagnosis of depression, prescription of a nontrial antidepressant, or nonpharmacologic treatment of depression. Analysis was on an intention-to-treat basis.
Results A total of 607 participants (378 men [62.3%]; mean [SD] age, 64.3 [12.2] years) were randomly assigned treatment with placebo, and 614 participants (397 men [64.7%]; mean [SD] age, 63.4 [12.4] years) were randomly assigned treatment with 20 mg of fluoxetine hydrochloride daily. The groups were balanced for demographic and clinical measures. At baseline, 112 patients (18.5%) in the placebo group and 116 patients (18.9%) in the fluoxetine group had PHQ-9 scores of 9 or higher. During follow-up, 126 of 596 participants (21.1%) treated with placebo and 121 of 598 participants (20.2%) treated with fluoxetine had PHQ-9 scores of 9 or higher (P = .70). A similar proportion of participants with PHQ-9 scores less than 9 at baseline who were treated with fluoxetine hydrochloride and placebo developed PHQ-9 scores of 9 or higher during the trial (placebo, 72 of 488 [14.8%]; and fluoxetine, 63 of 485 [13.0%]; P = .43). A slightly higher number of participants in the placebo group than in the fluoxetine group had a participant-reported clinician diagnosis of depression (42 of 602 [7.0%] vs 26 of 601 [4.3%]; P = .05). By week 26, 14 participants (2.3%) in the placebo group and 12 participants (1.9%) in the fluoxetine group had died (P = .67).
Conclusions and Relevance Routine daily treatment with 20 mg of fluoxetine did not decrease the proportion of people affected by clinically significant symptoms of depression after a stroke, nor did it affect the proportion of people prescribed an antidepressant or receiving nonpharmacologic treatments compared with placebo.
Trial Registration http://anzctr.org.au Identifier: ACTRN12611000774921
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