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<p>Cognitive disorders, including dementia, are a major challenge for public health systems worldwide, particularly among elderly individuals. The present study aimed to compare the effectiveness of donepezil alone versus donepezil combined with trazodone in improving cognitive dysfunction in dementia. In this randomized controlled trial, a total of 60 patients with dementia according to the DSM-V referred to the Babol University of Medical Sciences Center for Elderly individuals were randomly assigned to receive either donepezil 5–10 mg daily (Group A) or donepezil 5–10 mg plus trazodone 25–100 mg daily (Group B) for 6 months. Cognitive status was assessed at baseline, 3 months, and 6 months using the Mini-Mental State Examination (MMSE) and the Addenbrook’s scale. All adverse drug reactions were compared. Both groups showed significant improvement from baseline in MMSE and Adent Brook scores over 6 months (<i>p</i> &lt; 0.001). No significant differences in clinical efficacy or side effect reactions were observed between the groups (<i>p</i> &gt; 0.05). Tiredness was a more common side effect of the combination treatment. Adding trazodone to donepezil showed no cognitive benefits over donepezil alone. While trazodone may help with sleep and behavioral issues, it does not improve cognition in dementia patients. Larger studies with longer follow-ups and varied trazodone doses across dementia subtypes are needed. Iranian Registry for Clinical Trial (ID: IRCT20190317043079N1) registration date: 04/10/2019.</p>

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Efficacy of donepezil versus donepezil and trazodone in combination cognitive dysfunction in patients with dementia: a randomized controlled trial

  • 期刊论文

  • 发表日期：

    2025年6月30日

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  • Farzan Kheirkhah,
  • Mahasti Emami Hamzehkolaee,
  • Sorush Parvizi,
  • Soraya Khafri,
  • Ali Bijani,
  • Romina Hamzehpour

摘要

Cognitive disorders, including dementia, are a major challenge for public health systems worldwide, particularly among elderly individuals. The present study aimed to compare the effectiveness of donepezil alone versus donepezil combined with trazodone in improving cognitive dysfunction in dementia. In this randomized controlled trial, a total of 60 patients with dementia according to the DSM-V referred to the Babol University of Medical Sciences Center for Elderly individuals were randomly assigned to receive either donepezil 5–10 mg daily (Group A) or donepezil 5–10 mg plus trazodone 25–100 mg daily (Group B) for 6 months. Cognitive status was assessed at baseline, 3 months, and 6 months using the Mini-Mental State Examination (MMSE) and the Addenbrook’s scale. All adverse drug reactions were compared. Both groups showed significant improvement from baseline in MMSE and Adent Brook scores over 6 months (p < 0.001). No significant differences in clinical efficacy or side effect reactions were observed between the groups (p > 0.05). Tiredness was a more common side effect of the combination treatment. Adding trazodone to donepezil showed no cognitive benefits over donepezil alone. While trazodone may help with sleep and behavioral issues, it does not improve cognition in dementia patients. Larger studies with longer follow-ups and varied trazodone doses across dementia subtypes are needed. Iranian Registry for Clinical Trial (ID: IRCT20190317043079N1) registration date: 04/10/2019.