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Table 1 Study descriptions and number of subjects

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
  1. 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baseline, or ≥95 μg/ml and HAM-D ≥30% from baseline; cData obtained from Abbott Protocol M99-082 clinical study report (unpublished).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.