Table 1

Study descriptions and number of subjects

Indication

Study and year of publication

Description

Treatment duration, weeks

Dose and/or target trough drug level

Treatment group

Total, N = 2,319


DVPX, N = 1,327

Placebo, N = 992


Placebo-controlled studies


Epilepsy

Willmore et al. 1996 [30]

Adjunctive therapy in CPS

16

90 mg/kg/day max

77

70

147


Total

77 (6%)

70 (7%)

147 (6%)


Psychiatric

Pope et al. 1991 [31]

Acute maniaa

3

50-100 μg/ml

20

23

43


Bowden et al. 1994 [32]

Acute maniaa

3

150 μg/ml

69

74

143


Bowden et al. 2000 [33]

Mania maintenance

52

71-125 μg/ml

187

94

281


Sachs et al. 2001 [34]

Bipolar depression

16

250 mg/day initial with titrationb

23

22

45


Hirschfeld et al. 2010 [35]

Acute maniaa

3

20 mg/kg/day with increases allowed

146

78

224


Tariot et al. 2001 [36]

Dementiaa

6

30 mg/kg/day max

87

85

172


Bowden et al. 2006 [37]

Acute maniaa

3

85-125 μg/ml

192

185

377


Hollander et al. 2003 [38]

Impulsive aggression

12

80-120 μg/ml, 30 mg/kg/day max

124

122

246


Placebo-controlled studyc

Dementiaa

6

500 or 1,000 mg/day

78

43

121


Total

926 (70%)

726 (73%)

1652 (71%)


Migraine

Mathew et al. 1995 [39]

Migraine prophylaxis

12

70-120 μg/ml

70

37

107


Klapper 1997 [40]

Migraine prophylaxis

12

500, 1,000 or 1,500 mg/day

132

44

176


Freitag et al. 2002 [41]

Migraine prophylaxis

12

500 or 1,000 mg/day

122

115

237


Total

324 (24%)

196 (20%)

520 (22%)


High-dose DVPX vs low-dose DVPX


Trough levels

High-dose DVPX

Low-dose DVPX


Epilepsy

Beydoun et al. 1997 [42]

Monotherapy in CPS

24

25-50 μg/ml and 80-150 μg/ml

131

134

265


aInpatient study; all others were conducted in an outpatient setting; binitiated at 250 mg, titrated by 250 mg/day on alternate days until reaching one of three criteria: serum trough concentration ≥45 μg/ml and HAM-D improvement ≥60% from baseline, ≥75 μg/ml and HAM-D ≥50% from baseline, or ≥95 μg/ml and HAM-D ≥30% from baseline; cData obtained from Abbott Protocol M99-082 clinical study report (unpublished). CPS = complex partial seizures; DVPX = divalproex sodium; HAM-D = Hamilton Rating Scale for Depression.

Redden et al. Annals of General Psychiatry 2011 10:1   doi:10.1186/1744-859X-10-1

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