Background/Aims: To evaluate the efficacy and safety of venlafaxine in the treatment of major depression in dementia. Methods: Thirty-one outpatients who had dementia and major depression participated in this randomized, double-blind, placebo-controlled, 6-week, flexible dose clinical trial. The screening measures were Cornell Scale for depression in dementia, DSM-IV for depression and dementia and Mini-Mental State Examination. The outcome measures were response rate, Montgomery-Åsberg Depression Rating scale and Clinical Global Impressions. Results: The percentage of patients defined as Montgomery-Åsberg Depression Rating scale responders was approximately the same in the placebo and in the venlafaxine groups. Clinical Global Impressions showed no significant difference between the groups. The reasons for dropouts show borderline significance between the two groups. There was no statistically significant difference in the incidence of adverse events between the venlafaxine and placebo-treated groups. Conclusions: Our data do not support the hypothesis that venlafaxine improves mood in elderly demented patients.

Objective: To evaluate the efficacy and tolerability of ziprasidone in behavioral and psychological symptoms of dementia. Method: A 7-week open-label trial of ziprasidone. Results: Of the 25 patients who participated, 15 completed the study. The main reason for discontinuation was adverse events. The mean total Neuropsychiatric Inventory (NPI) score fell significantly from 47.1 ± 17.1 (baseline) to 25.8 ± 17.9 (day 49) (p < 0.01). The NPI caregiver burden showed a significant improvement from 22.6 ± 8.3 at baseline to 11.8 ± 7.3. The most frequent adverse events were somnolence, gastrointestinal symptoms and parkinsonism. Conclusions: Ziprasidone was able to significantly improve distressing non-cognitive symptoms of dementia although adverse effects occurred. Additional large-scale, double-blind, well-controlled studies are necessary to evaluate the use of ziprasidone in this indication.

This study showed no significant therapeutic effects of 15-mg mirtazapine in community-dwelling Alzheimer's disease patients with sleep disorders. Instead, this study found evidence of worsening of daytime sleep patterns.

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