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Affinity designer trial10/11/2023 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. The groups were balanced for demographic and clinical measures. Analysis was on an intention-to-treat basis.Ī total of 607 participants (378 men mean age, 64.3 years) were randomly assigned treatment with placebo, and 614 participants (397 men mean age, 63.4 years) were randomly assigned treatment with 20 mg of fluoxetine hydrochloride daily. Other outcomes of interest included participant-reported clinician diagnosis of depression, prescription of a nontrial antidepressant, or nonpharmacologic treatment of depression. Assessments were completed at baseline and at 4, 12, and 26 weeks. 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.įluoxetine hydrochloride, 20 mg, or matched placebo daily for 26 weeks.Ī 9-item Patient Health Questionnaire (PHQ-9) score of 9 or lower was a prespecified secondary outcome of the trial. 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. 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. 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.
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