Table 25Placebo-controlled trials of atypical antipsychotics in patients with behavioral and psychological symptoms of dementia

Study, Year (quality)Medications compared (mean daily dose)NDurationMain efficacy results
de Deyn, 2005 (fair)Aripiprazole 2 mg
Placebo
20810 weeksNo difference from placebo on NPI Total or Psychosis scores, CGI-S or CGI-I.
Aripiprazole superior to placebo on BPRS Psychosis and Core scores, no difference from placebo in BPRS Total score at endpoint (although superior to placebo at week 6)
Mintzer, 2007 (fair)Aripiprazole 2 mg
Aripiprazole 5 mg
Aripiprazole 10 mg
Placebo
48710 weeksAripiprazole 10 mg: superior to placebo on NPI-NH, BPRS Total, BPRS Core, CMAI, and CGI-S.
Aripiprazole 5 mg: superior to placebo on BPRS Core, CMAI, but not CGI-I.
Aripiprazole 2 mg: No difference from placebo on any outcome
Rappaport, 2009 (fair)Intramuscular aripiprazole 5 mg, 10 mg or 15 mg
Placebo
12924 hoursAll aripiprazole doses superior to placebo at 30 minutes, aripiprazole 10 mg and 15 mg doses superior to placebo at all time points.
Streim, 2008 (fair)Aripiprazole 9 mg (range 0.7 to 15.0 mg)
Placebo
25610 weeksNo difference between groups on NPI-NH Psychosis scale or CGI-S (primary endpoints)

Secondary outcomes: Aripiprazole had better efficacy than placebo on NPI-NH Total Caregiver Distress, BPRS-Total, BPRS Core, Cornell scale, and NPI-NH Total response rate.

No difference from placebo on BPRS Psychosis, BPRS Core, NPI-NH
Psychosis Care Distress, MMSE, or NPI-NH Psychosis response rate
Street, 2000 (good)Olanzapine 5 mg
Olanzapine 10 mg
Placebo
2066 weeksOlanzapine superior to placebo on NPI-NH and BPRS
de Deyn, 2004 (fair)Olanzapine 1 mg
Olanzapine 2.5 mg
Olanzapine 5 mg
Olanzapine 7.5 mg
Placebo
65210 weeksMixed results:
Only 7.5 mg dose superior to placebo on NPI-NH Total, NPI-NH psychosis.
No difference compared with placebo on BPRS.
Meehan, 2002 (fair)Intramuscular short-acting olanzapine
Lorazepam 1 mg
Placebo
27224 hoursSignificant effect compared with placebo; no difference between olanzapine and lorazepam.
Ballard, 2005 (fair)Quetiapine IR
Rivastigmine
Placebo
9326 weeksNo difference compared with placebo on CMAI.
Quetiapine IR superior to placebo on Severe Impairment Battery.
Zhong, 2007 (fair)Quetiapine IR 100 mg
Quetiapine IR 200 mg
Placebo
33310 weeksNo difference compared with placebo on primary outcome measure PANSS-EC. Improvement on
CGI-C (200 mg only). No difference from placebo on NPI-NH or CMAI.
Brodaty, 2003 (fair)Risperidone
Placebo
30912 weeksRisperidone superior to placebo on CMAI (total and 4 of 5 subscales) and BEHAVE-AD (total and 5 of 7 subscales)
Katz, 1999 (fair)Risperidone 0.5 mg
Risperidone 1 mg
Risperidone 2 mg
Placebo
62512 weeksRisperidone 1 mg and 2 mg superior to placebo on BEHAVE-AD.
No difference compared with placebo at 0.5 mg dose.
Mintzer, 2006 (fair)Risperidone
Placebo
4738 weeksNo difference compared with placebo on BEHAVE-AD or CGI-C

Abbreviations: IR, immediate release.

From: Results

Cover of Drug Class Review: Atypical Antipsychotic Drugs
Drug Class Review: Atypical Antipsychotic Drugs: Final Update 3 Report [Internet].
McDonagh M, Peterson K, Carson S, et al.
Portland (OR): Oregon Health & Science University; 2010 Jul.
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