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Purpose <p>To investigate the effects of fluoxetine on the levels of depression and anxiety in hemodialysis patients.</p> Methods <p>In this 8-week randomized double-blind placebo-controlled study, chronic hemodialysis patients who were 18 to 80&#xa0;years old were assigned to receive a placebo or fluoxetine capsule. Of the 295 screened patients, 54 were diagnosed with major depressive disorder, and 31 were assigned into the fluoxetine or placebo group. Finally, 19 patients completed the trial. The severity of depression and anxiety were assessed biweekly via the Beck Depression Inventory-II (BDI-II) and the anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A), respectively. The statistical package for the social sciences software, version 20 was used for data analysis. Generalized estimating equations (marginal model) were used to compare the changes in the BDI-II and HADS-A scores between the two groups.</p> Results <p>At the end of week 8, the BDI-II score in the fluoxetine group was significantly lower than that in the placebo group (β = -19.22, 95% CI −25.62 to −12.51, P &lt; 0.001). However, the score of the HADS-A did not show a significant difference between the two groups (β = −4.24, 95% CI −16.19 to 7.71, P = 0.487). Ten patients reported side effects which were more common in the fluoxetine group.</p> Conclusions <p>Compared with placebo, fluoxetine significantly decreased the depression severity. However, this study did not show a significant effect of fluoxetine on the severity of anxiety. Larger, long-term studies are warranted to validate these findings.</p> Trial registration <p>The study protocol was registered on IRCT.ir (registration number: IRCT20220422054611N1) (<a href="https://irct.behdasht.gov.ir/search/result?query=IRCT20220422054611N1">https://irct.behdasht.gov.ir/search/result?query=IRCT20220422054611N1</a>), Registration date: 2022-05-27.</p>

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Evaluation of the effect of fluoxetine on depression and anxiety levels in hemodialysis patients with major depressive disorder: a randomized, double-blind, placebo-controlled clinical trial

  • 期刊论文

  • 发表日期：

    2025年8月14日

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  • Fatemeh Askari,
  • Marjan Shamspour,
  • Tania Dehesh,
  • Najmeh Shamspour,
  • Farzaneh Jahanbakhsh,
  • Naemeh Nikvarz

摘要

Purpose

To investigate the effects of fluoxetine on the levels of depression and anxiety in hemodialysis patients.

Methods

In this 8-week randomized double-blind placebo-controlled study, chronic hemodialysis patients who were 18 to 80 years old were assigned to receive a placebo or fluoxetine capsule. Of the 295 screened patients, 54 were diagnosed with major depressive disorder, and 31 were assigned into the fluoxetine or placebo group. Finally, 19 patients completed the trial. The severity of depression and anxiety were assessed biweekly via the Beck Depression Inventory-II (BDI-II) and the anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A), respectively. The statistical package for the social sciences software, version 20 was used for data analysis. Generalized estimating equations (marginal model) were used to compare the changes in the BDI-II and HADS-A scores between the two groups.

Results

At the end of week 8, the BDI-II score in the fluoxetine group was significantly lower than that in the placebo group (β = -19.22, 95% CI −25.62 to −12.51, P < 0.001). However, the score of the HADS-A did not show a significant difference between the two groups (β = −4.24, 95% CI −16.19 to 7.71, P = 0.487). Ten patients reported side effects which were more common in the fluoxetine group.

Conclusions

Compared with placebo, fluoxetine significantly decreased the depression severity. However, this study did not show a significant effect of fluoxetine on the severity of anxiety. Larger, long-term studies are warranted to validate these findings.

Trial registration

The study protocol was registered on IRCT.ir (registration number: IRCT20220422054611N1) (https://irct.behdasht.gov.ir/search/result?query=IRCT20220422054611N1), Registration date: 2022-05-27.