A double-blind, placebo-controlled study of fluoxetine in depressed patients with Alzheimer's disease.
OBJECTIVE
To examine the efficacy of fluoxetine in the treatment of depression in patients with probable Alzheimer's disease (AD).


METHODS
This double-blind, parallel-design study included a consecutive series of 41 AD subjects meeting DSM-IV criteria for major or minor depression who were randomized to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiety, and the Functional Independence Measure as secondary efficacy measures.


RESULTS
Complete remission of depression was found in 47% of subjects treated with fluoxetine and in 33% of subjects treated with placebo. Both the fluoxetine and the placebo groups showed a significant decline in HAM-D scores over time, but the magnitude of mood improvement was similar for both groups. Fluoxetine was well tolerated, and most side effects were mild.


CONCLUSIONS
Fluoxetine treatment for depression in AD did not differ significantly from treatment with placebo. Our study also confirms the presence of a placebo effect in the treatment of depression in AD.
Petracca
G M
GM
Department of Neuropsychiatry and Neuropsychology, Raúl Carrea Institute of Neurological Research-FLENI, Buenos Aires, Argentina. gmp@fleni.org.ar
Chemerinski
E
E
Starkstein
S E
SE
D000368:Aged; D000544:Alzheimer Disease / Q000150:complications / Q000523:psychology*; D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine