Table 1.
Randomized placebo‐controlled trials of antipsychotics in dementia with neuropsychiatric symptoms related to dementia
| Author, Year | Antipsychotic | Setting | Neuropsychiatric Symptom | Run‐in Period (Duration in Weeks) | Patients Excluded After Run‐in, n (%) | Randomized Patients, n |
|---|---|---|---|---|---|---|
| Conventional antipsychotic trials (11) | ||||||
| Hamilton, 1962 | Trifluoperazine | Hospital | Diverse | No | NA | 27 |
| Sugerman, 1964 | Haloperidol | Hospital | Diverse | No | NA | 18 |
| Rada, 1976 | Thiothixene | Hospital | Diverse | Yes, with placebo (1) | 0 (0) | 42 |
| Barnes, 1982 | Thioridazine Loxapine | Nursing home | Diverse | Yes, with placebo (2) | 7 (11.7) | 53 |
| Petrie, 1982 | Haloperidol Loxapine | Hospital | Diverse | Yes, with placebo (2) | 0 (0) | 61 |
| Stotsky, 1984 | Thioridazine | Nursing home and hospital | Diverse | Yes, washout only (2) | NR | 358 |
| Finkel, 1995 | Thiothixene | Nursing home | Agitation | Yes, washout only (1) | 0 (0) | 33 |
| Auchus, 1997 | Haloperidol | Outpatients | Agitation | Yes, washout only (2) | 0 (0) | 12 |
| Devanand, 1998 | Haloperidol | Outpatients | Diverse | Yes, with placebo (1) | 5 (7.0) | 66 |
| Teri, 2000 | Haloperidol | Hospital | Agitation | Yes, washout only (2) | 0 (0) | 70 |
| Pollock, 2002 | Perphenazine | Nursing home | Diverse | Yes, washout only (<1) | NR | 54 |
| Atypical antipsychotic trials (21) | ||||||
| Satterlee, 1995 | Olanzapine | Nursing home | Psychosisa | Yes, washout only | 51 (17.7) | 238 |
| Janssen Ph, 1997 | Risperidone | NR | Diverse | Yes, with placebo (1) | NR | 39 |
| Katz, 1999 | Risperidone | Nursing home | Diverse | Yes, with placebo (1) | 104 (14.3) | 625 |
| Street, 2000 | Olanzapine | Nursing home | Diverse | Yes, with placebo (2) | 82 (28.5) | 206 |
| Brodaty, 2003 | Risperidone | Nursing home | Aggression | Yes, with placebo (1) | 39 (10.2) | 345 |
| Janssen Ph, 2003 | Risperidone | Nursing home | Psychosis | Yes, with placebo (1) | NR | 18 |
| De Deyn, 2004 | Olanzapine | Nursing home | Psychosis | Yes, with placebo (2) | NR | 652 |
| Ballard, 2005 | Quetiapine | Nursing home | Agitation | No | NA | 62 |
| De Deyn, 2005 | Aripiprazole | Outpatients | Psychosis | Yes, washout only (1) | NR | 208 |
| Deberdt, 2005 | Risperidone Olanzapine | Nursing home and outpatients | Psychosis | Yes, with placebo (2) | NR | 494 |
| Janssen Ph, 2005 | Risperidone | NR | Psychosis | Yes, with risperidone (1) | NR | 33 |
| Mintzer, 2006 | Risperidone | Nursing home | Psychosis | Yes, with placebo (1) | 87 (15.5) | 473 |
| Schneider, 2006 |
Risperidone Olanzapine Quetiapine |
Outpatients | Diverse | No | NA | 421 |
| Mintzer, 2007 | Aripiprazole | Nursing home | Psychosis | Yes, washout only (1) | NR | 487 |
| Zhong, 2007 | Quetiapine | Nursing home | Agitation | No | NA | 333 |
| Paleacu, 2008 | Quetiapine | Not reported | Diverse | Yes, with quetiapine (2) | NR | 40 |
| Streim, 2008 | Aripiprazole | Nursing home | Psychosis | Yes, washout only (1) | NR | 256 |
| Otsuka Ph, 2017a | Brexpiprazole | Nursing home | Agitation | Yes, washout only (6) | NR | 413 |
| Otsuka Ph, 2017b | Brexpiprazole | Nursing home and outpatients | Agitation | Yes, washout only (6) | NR | 270 |
| ACADIA, 2018 | Pimavanserin | Nursing home and outpatients | Agitation | Yes, washout only (4) | NR | 111 |
| Ballard, 2018 | Pimavanserin | Nursing home | Psychosis | Yes, washout only (3) | 25 (12.1) | 181 |
| Trials with conventional and atypical antipsychotic drug group (3) | ||||||
| Allain, 2000 |
Tiapride Haloperidol |
Nursing home and hospital | Agitation | No | NA | 306 |
| De Deyn, 1999 |
Risperidone Haloperidol |
Nursing home | Diverse | Yes, with placebo (1) | 27 (7.3) | 344 |
| Tariot, 2006 |
Quetiapine Haloperidol |
Nursing home | Psychosis | Yes, washout only (1)b | 123 (24.6) | 284 |
Abbreviations: NA not applicable; NR, not reported; Ph, pharmaceuticals.
a
Reduction measured with generic instrument (in all other studies indication and outcome scale were congruent).
b
At least 2 days.