Treating Depression in Alzheimer Disease: Efficacy and Safety of Sertraline Therapy, and the Benefits of Depression Reduction: The DIADS | Dementia and Cognitive Impairment | JAMA Psychiatry | JAMA Network
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Original Article
July 2003

Treating Depression in Alzheimer Disease: Efficacy and Safety of Sertraline Therapy, and the Benefits of Depression Reduction: The DIADS

Author Affiliations

From the Division of Geriatric Psychiatry and Neuropsychiatry and Division of Medical Psychology, Department of Psychiatry and Behavioral Sciences, School of Medicine (Drs Lyketsos, DelCampo, Steinberg, Munro, Baker, Brandt, and Rabins, Mr Miles, and Mss Steele and Sheppard), Department of Biostatistics, Bloomberg School of Public Health (Ms Sheppard and Dr Frangakis), The Johns Hopkins University, Baltimore, Md; and The Copper Ridge Institute, Sykesville, Md (Drs Lyketsos, Steinberg, Baker, Brandt, and Rabins and Ms Steele).

Arch Gen Psychiatry. 2003;60(7):737-746. doi:10.1001/archpsyc.60.7.737
Abstract

Context  Major depression affects about 25% of the patients who have Alzheimer disease and has serious adverse consequences for patients and caregivers. Results of prior antidepressant treatment studies have produced contradictory findings and have not fully assessed the benefits of depression reduction.

Objectives  To assess the efficacy and safety of sertraline hydrochloride for the treatment of major depression in Alzheimer disease, and to evaluate the effect of depression reduction on activities of daily living, cognition, and nonmood behavioral disturbance.

Design  Randomized, placebo-controlled, parallel, 12-week, flexible-dose clinical trial with a 1-week, single-blind placebo phase. The study was conducted between January 1, 1998, and July 19, 2001.

Setting  University outpatient clinic.

Participants  Forty-four outpatients who have probable Alzheimer disease and major depressive episodes.

Intervention  Sertraline hydrochloride, mean dosage of 95 mg/d, or identical placebo, randomly assigned.

Main Outcome Measures  Response rate, Cornell Scale for Depression in Dementia, Hamilton Depression Rating Scale, Mini-Mental State Examination, Psychogeriatric Depression Rating Scale–activities of daily living subscale, and Neuropsychiatric Inventory to quantify patient behavior disturbance and caregiver distress.

Results  In the sertraline-treated group 9 patients (38%) were full responders and 11 (46%) were partial responders compared with 3 (20%) and 4 (15%), respectively, in the placebo-treated group (P = .007). The sertraline-treated group had greater improvements in the scores for the Cornell Scale for Depression in Dementia (P = .002) and Hamilton Depression Rating Scale (P = .01), and a statistical trend toward less decline in activities of daily living on the Psychogeriatric Depression Rating Scale–activities of daily living subscale (P =.07). There was no difference between the treatment groups in Mini-Mental State Examination (P = .22) or Neuropsychiatric Inventory(P = .32) ratings over time. When full responders, partial responders, and nonresponders were compared, full responders only, or full and partial responders had significantly better ratings on activities of daily living (P = .04), behavioral disturbance(P = .01), and caregiver distress (P = .006), but not on the Mini-Mental State Examination (P = .76). Safety monitoring indicated few differences in adverse effects between the 2 treatment groups.

Conclusions  Sertraline is superior to placebo for the treatment of major depression in Alzheimer disease. Depression reduction is accompanied by lessened behavior disturbance and improved activities of daily living, but not improved cognition.

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