Table 5Dementia—PCTs contributing to meta-analyses

Author, YearSubjectsNTreatmentsDurationOutcomes
Breder et al. 2004146Psychosis/psychotic features, Nursing home resident, NPI or NPI/NH >= 6 sum of hallucinations and delusional items, Age 55-95, MMSE = 6-22487Placebo

Aripiprazole 5 mg/day

Aripiprazole 2 mg/day

Aripiprazole 10 mg/day
10 weeksTotal/Global Scores:
Aripiprazole vs. Placebo-SMD =0.15 (-0.06, 0.36)

Psychosis score:
Aripiprazole vs Placebo-SMD = 0.20 (-0.01, 0.41)

Agitation score:
Aripiprazole vs Placebo-SMD = 0.27 (0.05, 0.48)
DeDeyn et al. 2003102AD with psychosis208Placebo

Aripiprazole 2–15 mg/day
10 weeksTotal/Global Scores
Aripiprazole vs Placebo - SMD =0.06 (-0.21, 0.34)

Psychosis score:
Aripiprazole vs Placebo-SMD = 0.16 (-0.12, 0.43)
Mintzer et al. 2007107Diagnosed with AD and delusions / hallucinations. Institutionalized, capable of self-locomotion, MMSE 6-22. NPI-NH score >=6487Placebo

Aripiprazole 2 mg/day

Aripiprazole 5 mg/day

Aripiprazole 5-10 mg/day
10 weeksTotal/Global Scores
Aripiprazole vs Placebo - SMD = 0.16 (-0.05, 0.37)

Psychosis score:
Aripiprazole vs Placebo-SMD =0.24 (0.03, 0.45)

Agitation score:
Aripiprazole vs Placebo-SMD = 0.31 (0.10, 0.52)
Streim et al. 2004147
Streim et al. 2008108
AD with psychosis, Age 55-95, MMSE = 6-22, NPI or NPI/NH ≥ 6 sum of hallucinations and delusional items, hallucinations and delusions >=1 month256Placebo

Aripiprazole 8.6 mg/day
10 weeksTotal/Global Scores
Aripiprazole vs Placebo - SMD =0.36 (0.11, 0.61)

Psychosis score:
Aripiprazole vs Placebo-SMD = -0.02 (-0.27, 0.23)

Agitation score:
Aripiprazole vs Placebo-SMD = 0.30 (0.05, 0.55)
DeDeyn et al. 2004111Age >= 40, Hospitalized/ institutionalized, Psychosis/psychotic features, MMSE = 5-26NRPlacebo

Olanzapine 1.0 mg/day

Olanzapine 2.5 mg/day

Olanzapine 5.0 mg/day

Olanzapine 7.5 mg/day
10 weeksTotal/Global Scores
Olanzapine vs Placebo - SMD = 0.14 (-0.05, 0.34)

Psychosis score:
Olanzapine vs Placebo-SMD = 0.17 (-0.02, 0.37)

Agitation score:
Olanzapine vs Placebo-SMD =0.14 (-0.05, 0.33)
Deberdt et al. 2004116Age >= 40, AD, vascular or mixed dementia, NPI or NPI/NH >= 6 sum of hallucinations and delusional items494Placebo

Olanzapine 5.2 mg

Risperidone 1.0 mg
10 weeksTotal/Global Scores
Olanzapine vs Placebo - SMD = -0.02(-0.27, 0.23)

Total/Global Scores
Risperidone vs Placebo - SMD =-0.13 (-0.38, 0.12)

Psychosis score:
Olanzapine vs Placebo-SMD =-0.12 (-0.36, 0.13)

Risperidone vs Placebo-SMD =-0.03 (-0.34, 0.16)

Agitation score:
Olanzapine vs Placebo-SMD =0.09 (-0.16, 0.34)

Risperidone vs Placebo-SMD =0.14 (-0.11, 0.39)
Kennedy et al. 2005118Age ≥ 40, MMSE 14-26268Placebo

Olanzapine 2.5-7.5 mg/day
26 weeksPsychosis score:
Olanzapine vs Placebo-SMD =-0.07 (0.33, 0.18)
Schneider, et al. 2006148
Sultzer et al. 2008119
AD or probable AD, MMSE 5-26, psychosis, aggression, or agitation previous week or at least intermittently for 4 weeks, had a severity rating of at least “moderate” for conceptual disorganization, suspiciousness, or hallucinatory behavior on (BPRS), ambulatory and living at home or in an assisted-living facility421Placebo

Olanzapine 5.5mg/day

Quetiapine 56.5 mg/day

Risperidone 1.0 mg/day
12 weeksTotal/Global Scores
Olanzapine vs Placebo - SMD =0.15 (-0.11, 0.40)

Quetiapine vs Placebo - SMD = 0.15 (-0.11, 0.40)

Risperidone vs Placebo - SMD =0.40 (0.13, 0.68)

Psychosis score:
Olanzapine vs Placebo-SMD =0.07 (-0.19, 033)

Quetiapine vs Placebo- SMD =0.16 (-0.10, 0.42)

Risperidone vs Placebo- SMD =0.38 (0.11, 0.66)

Agitation score:
Olanzapine vs Placebo- SMD =0.28 (0.02, 0.53)

Quetiapine vs Placebo- SMD =0.20 (-0.06, 0.46)

Risperidone vs Placebo- SMD =0.10 (-0.17, 0.37)
Street et al. 2000110Possible or probable AD, NPI/NH ≥ 3206Placebo

Olanzapine 5 mg/day

Olanzapine 10 mg/day

Olanzapine 15 mg/day
6 weeksTotal/Global Scores
Olanzapine vs Placebo - SMD = 0.30 (-0.03, 0.63)

Psychosis score:
Olanzapine vs Placebo- SMD =0.17 (-0.17, 0.50)

Agitation score at 9 weeks:
Olanzapine vs Placebo- SMD =0.39 (0.05, 0.72)
Ballard et al. 2005121CMAI >= 39,Age >= 60, NPI >= 493Placebo Rivastigmine min 9 mg/day Quetiapine 100 mg/day26 weeksAgitation score:
Quetiapine vs Placebo- SMD =-0.13 (-0.66, 0.39)
Paleacu et al. 2008123AD with BPSD, age > 50, MMSE < 24, NPI > 6 on any item40Placebo

Quetiapine 50-300 mg/day
6 weeksAgitation score:
Quetiapine vs Placebo- SMD =-0.48 (-1.11, 0.15)
Tariot et al. 2006124Diagnosed with DSM-IV AD, > 64 years old, not bedridden, nursing home residents for >= 2 weeks, presence of psychosis, BPRS scores >=24, CGI-S scores >=4, scores of >= 3 on two or more BPRS items, frequency scores of >= 3 on at least one of the two psychosis items of the NPI-NH, scores of >= 5 on MMSE284Placebo

Haloperidol 0.5-12 mg/day

Quetiapine 25-600 mg/day
10 weeksTotal/Global Scores
Quetiapine vs Placebo - SMD =0.22 (-0.07, 0.28)

Agitation score:
Quetiapine vs Placebo- SMD =0.24 (-0.05, 0.54)

Psychosis score:

Quetiapine vs. Placebo – SMD = 0.00 (-0.29, 0.30)
Zhong et al. 2004149
Zhong et al. 2007122
Institutionalized, diagnosed possible AD or vascular dementia, age >= 55, ambulatory, agitation that didn't result directly from participants medical condition, PANSS-EC total >= 14, one of the 5 PANSS-EC items >= 4.333Placebo

Quetiapine 100 mg/day

Quetiapine 200 mg/day
10 weeksTotal/Global Scores
Quetiapine vs Placebo - SMD =0.04 (-0.21, 0.28)

Psychosis score:
Quetiapine vs Placebo - SMD =-0.03 (-0.27, 0.21)

Agitation score:
Quetiapine vs Placebo - SMD =-0.03 (-0.27, 0.21)
Brodaty et al. 2003126
Brodaty et al. 2005150
Age >= 55, FAST > = 4,MMSE< = 23, CMAI score of >= 4 on at least 1 aggressive item or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3, Nursing home resident, Resident >= 1 month prior to enrollment345Placebo 1.06 mg/day

Risperidone 0.95 mg/day
12 weeksTotal/Global Scores
Risperidone vs Placebo - SMD = 0.46 (0.23, 0.69)

Psychosis score:
Risperidone vs Placebo- SMD =0.36 (0.13, 0.59)

Agitation score:
Risperidone vs Placebo- SMD =0.37 (0.14, 0.59)
Dedeyn et al. 1999125Age >= 55, Hospitalized/institutionalized, FAST >= 4, MMSE <= 23, BEHAVE-AD behavior pathology > 1, BEHAVE-AD >= 8344Placebo

Haloperidol 1.2 mg/day

Risperidone 1.1 mg/day
12 weeksTotal/Global Scores
Risperidone vs Placebo - SMD =0.12 (-0.14, 0.38)

Agitation score:
Risperidone vs Placebo- SMD =0.31 (0.05, 0.57)
Katz et al. 1999127Age >= 55, FAST >= 4, MMSE <= 23, BEHAVE-AD >= 8, BEHAVE-AD global rating >= 1625Placebo
Risperidone 0.5 mg/day

Risperidone 1 mg/day

Risperidone 2 mg/day
12 weeksTotal/Global Scores
Risperidone vs Placebo - SMD = 0.32 (0.11, 0.53)

Psychosis score:
Risperidone vs Placebo- SMD =0.20 (-0.01, 0.41)

Agitation score:
Risperidone vs Placebo- SMD =0.38 (0.17, 0.60)
Mintzer et al. 2006129>= 55 years old, residents of nursing homes or long-term care facilities, mobile, met the criteria for psychosis of AD, in need of treatment with an atypical antipsychotic, scored >=2 on any item of the BEHAVE-AD psychosis subscale, MMSE 5-23473Placebo

Risperidone 0.5-2.5 mg/day
8 weeksTotal/Global Scores:
Risperidone vs Placebo - SMD =-0.01 (-0.21, 0.18)

Psychosis score:
Risperidone vs Placebo- SMD =0.17 (-0.02, 0.36)

Agitation score:
Risperidone vs Placebo- SMD =0.04 (-0.16, 0.23)

AD = Alzheimer's disease; BEHAVE-AD = Behavioral Pathology in Alzheimer's Disease Scale; BPRS = Brief Psychiatric Rating Scale; BPSD = Behavioral and Psychological Symptoms of Dementia; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition; FAST = ; MMSE = Mini Mental Status Exam; PANSS-EC = Positive and Negative Syndrome Scale-Excited Component; SMD = standardized mean difference

From: Results

Cover of Off-Label Use of Atypical Antipsychotics: An Update
Off-Label Use of Atypical Antipsychotics: An Update [Internet].
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