From: Suicidality and divalproex sodium: analysis of controlled studies in multiple indications
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 |