Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.

Full 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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Author information

Author/s: Lyketsos, Constantine G (CG); DelCampo, Lourdes (L); Steinberg, Martin (M); Miles, Quincy (Q); Steele, Cynthia D (CD); Munro, Cynthia (C); Baker, Alva S (AS); Sheppard, Jeannie-Marie E (JM); Frangakis, Constantine (C); Brandt, Jason (J); Rabins, Peter V (PV);

Affiliation: Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, School of Medicine, The Johns Hopkins University, Baltimore, MD, USA. kostas(-atsign-)jhmi.edu

Grants: 1R01-MH56511 (Agency:NIMH NIH HHS)

Journal and publication information

Publication Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.

Journal: Archives of general psychiatry (Arch Gen Psychiatry), published in United States. (Language: eng)

Reference: 2003-Jul; vol 60 (issue 7) : pp 737-46

Dates: Created 2003/07/15; Completed 2003/09/16; Revised 2007/11/14;

PMID: 12860778, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Activities of Daily Living - psychology
Aged
Alzheimer Disease - drug therapy; epidemiology; psychology
Ambulatory Care
Caregivers - psychology
Cognition Disorders - diagnosis; psychology
Comorbidity
Depressive Disorder - drug therapy; epidemiology; psychology
Drug Administration Schedule
Female
Geriatric Assessment

Geriatric Assessment
Humans
Male
Mental Disorders - diagnosis; psychology
Neuropsychological Tests
Placebos
Psychiatric Status Rating Scales
Serotonin Uptake Inhibitors - therapeutic use
Sertraline - therapeutic use
Single-Blind Method
Treatment Outcome

Associated Chemicals: Placebos (0) ; Serotonin Uptake Inhibitors (0) ; Sertraline (79617-96-2)

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