Table 1 Characteristics of included studies

Burns et al., 2009 [57]

6 months

407

83.7/83.5

8.8/9.1

Galantamine:

24 mg/day target dose (12 mg twice a day). Dose reduction to 8 mg twice a day to improve tolerability was possible.

Placebo.

MDS-ADL, SIB

Significantly improved cognitive function. No significant improvement in the co-primary outcome of ADLs.

Tariot et al., 2001 [58]

24 weeks

208

85.4/85.9

14.4

Donepezil:

10 mg/day target dose. Dose reduction to improve tolerability was possible.

Placebo.

CDR-SoB, MMSE, NPI-NH, PSMS

Donepezil-treated patients improved or maintained in cognition. Impact of donepezil on BPSD remains unclear.

Petracca et al., 1996 [59]

(cross-over trial)

2 × 6 week treatment period, separated by a 2-week wash-out period

24

71.5/72.4

21.0/22.1

Clomipramine: 100 mg/day target dose.

Placebo.

FIM, HAM-D, MMSE

Clomipramine was significantly more effective in lowering depression scores compared to placebo. No changes in ADL measures.

Petracca et al., 2001 [56]

6 weeks

41

70.2/71.3

23.2

Fluoxetine:

40 mg/day target dose.

Placebo.

CGI-I, FIM, HAM-A, HAM-D, MMSE

No significant differences in treatment effects on depression comparing fluoxetine and placebo.

Olin et al., 2001 [60]

6 weeks

21

74.7

5.9/6.1

Carbamazepine: 400 mg/day target dose.

Placebo.

BPRS, CGI-I, HAM-D, IADL, MMSE, PSMS

Modest clinical benefit in global impression and a particular benefit for hostile behaviour in carbamazepine-treated patients was shown.

Porsteinsson et al., 2001 [61]

6 weeks

56

85.3/84.7

7.0/6.7

Carbamazepine: 375 mg/day starting dose, followed by flexible dose regimen.

Placebo.

BPRS, CERAD BRSD, CGI-I, MMSE, OAS, PSMS

Possible short-term efficacy of valproate in reduction of agitation in patients with dementia in the nursing home.

Tariot et al., 1994 [62]

(cross-over trial)

2 × 5 week treatment period, separated by a 2 week wash-out period

25

84.5

7.6

Carbamazepine: 100–800 mg/day based on physician’s review.

BPRS, CGI-I, DMAS, MMSE, OAS, PSMS

Short-term therapy with Carbamazepine may have beneficial effects on BPSD in patients with dementia and agitation (significant reduction in BPRS total score).

Tariot et al., 1998 [63]

6 weeks

51

87.1/84.8

3.9/8.3

Carbamazepine: 100 mg/day starting dose, increased by 50 mg/day every 2–4 days; in the absence of toxicity a serum level of 5–8 μg/ml was maintained.

Placebo.

BPRS, CERAD BRSD, CGI-I, MMSE, PSMS

Carbamazepine showed significant short-term efficacy for agitation. Significant reduction of the BPRS agitation and hostility factor compared with placebo.

Tariot et al., 2006 [64]

10 weeks

284

Q: 81.9

H: 83.6

P: 83.9

Q: 12.4

H: 12.7

P: 13.2

Quetiapine:

100 mg/day target dose, maximum dose of 600 mg/day according to clinical response and tolerability

Haloperidol:

2 mg/day target dose, maximum dose of 12 mg/day according to clinical response and tolerability.

Placebo.

AIMS, BPRS, CGI-S, MMSE, MOSES, NPI-NH, PSMS, SAS

No significant improvement in BPRS total scores. Inconsistent significant improvement in some parts of BPSD for haloperidol treated patients. Tolerability was better for quetiapine compared with haloperidol.

Teranishi et al., 2013 [65]

8 weeks

82

R: 80.7

F: 83.2

Y: 83.5

R: 5.2

F: 4.5

Y: 4.4

Flexible oral dosing regimen.

Risperidone:

0.5–2 mg/day target dose.

Fluvoxamine:

25–200 mg/day target dose.

Yokukansan: 2.5–7.5 g/day target dose.

DIEPSS, FIM, MMSE, NPI-NH

NPI-NH scores decreased in all three groups with no significant differences.

Tolerability for yokukansan and quetiapine seemed to be more favourable than for risperidone.