Table 2.
Published clinical trials of topiramate in affective disorders
| Reference | Study design | Patients (n) Diagnosis | Mean dose (range) | Trial duration | Primary outcomes |
|---|---|---|---|---|---|
| Marcotte (1998) | Open-label study of add-on TPM in refractory BD | 58
BD I and II, other psychiatric disorders |
200 mg/day (25–400) | 16 weeks | 62% marked or moderate improvement based on a CGI equivalent scale (modified Likert scale) |
| Chengappa et al (1999) | Open-label study of add-on TPM in refractory BD | 20
BD I (18), schizoaffective disorder (2) |
210 mg/day (100–300) | 5 weeks | 60% much or very much improved based on ≥50% reduction in YMRS and CGI-BP scores |
| McElroy et al (2000) | Open-label study of add-on TPM in refractory BD | 56
BD I and II |
245 mg/day (50–1200) | 30 weeks | 63% initially manic and 27% initially depressed much or very much improved based on CGI-BP, YMRS, and IDS scores |
| Eads and Kramer (2000) | Open-label study of add-on TPM in refractory BD | 17
BD I (4), schizoaffective disorder (7), schizophrenia (6) |
826 mg/day (50–1600) | 32 weeks | 47% significantly improved based on GAF score |
| Vieta et al (2001) | Open-label study of add-on TPM in refractory BD | 21
BD I and II, manic (9), hypomanic (3) and depressed (6) phases |
158 mg/day | 6 weeks | 28% showed decrease ≥50% in YMRS or HAM-D scores and decrease by >2 points in CGI-BP score |
| Vieta et al (2002) | Open-label study of add-on TPM in refractory BD | 34
BD I (28), BD II (3), BD NOS (2), and schizoaffective disorder (1) |
200 mg/day (100–400) | 24 weeks | 59% initially manic and 55% initially depressed showed significant reduction in YMRS, HAM-D, and CGI-BP scores |
| Likouras et al (2004) | Open-label study of add-on TPM in refractory BD | 56
BD I |
290 mg/day (200–400) | 52 weeks | Frequency of manic and depressive episodes significantly decreased from 1.31 (±0.13) to 0.52 (±0.07) |
| Kusumakar et al (1999) | Open-label study of add-on TPM in rapid-cycling BD | 27
Rapid-cycling women (BP I=9; BP II=18) |
105 mg/day (100–150) | 16 weeks | 56% significantly improved based on HAM-D and YMRS scores |
| Grunze et al (2001) | Open-label study of add-on TPM in acute mania | 11
BD I – acute mania |
170 mg/day (25–200) | 10 days on, 5 days off, 10 days on | 64% and 73% showed YMRS ≥50% improvement in 1st and 2nd trial, respectively |
| Bozikas et al (2002) | Open-label study of add-on TPM in acute mania | 14
Acute mania |
310 mg/day (150–700) | 4 weeks | 61.5% showed a significant response (≥50% reduction in BRMS score) |
| Bahk et al (2005) | Open-label study of add-on TPM in acute mania | 33
Bipolar mania |
220 mg/day | 6 weeks | Overall significant decrease in YMRS (by 67.9%) and CGI (by 56.6%) scores |
| Hussain and Chaudhry (1999) | Open-label study of add-on TPM in bipolar depression | 45
BD I (27) and II (18) – major depressive episode |
275 mg/day (100–400) | 24 weeks | 42% showed complete remission (HAM-D scores between 3 and 7) and 27% showed partial remission (HAM-D scores between 8 and 12) |
| McIntyre et al (2002) | Open-label study of add-on TPM in bipolar depression | 18
BD I and II – depressed phase |
176 mg/day (50–300) | 8 weeks | 56% showed ≥50% reduction from baseline in HAM-D score |
| Guille and Sachs (2002) | Open-label study of add-on TPM in BD with psychiatric comorbidity | 14
BD I and II, with comorbid conditions |
100 mg/day (25–300) | 1–64 weeks (22 mean) | 64% showed increased level of functioning (4- to 15-point improvement in GAF score) |
| Calabrese et al (2001) | Open-label study of TPM as monotherapy in acute mania | 10
BD I – acute mania |
313 mg/day (50–612) | 2–28 days (16 mean) | 30% showed ≥50% decrease in YMRS score; 20% showed 25%–49% decrease in YMRS score |
Abbreviations: BD, bipolar disorder; BRMS, Bech and Rafaelsen Mania Scale; CGI, Clinical Global Impression; CGI-BP, Clinical Global Impression-Bipolar version; GAF, Global Assessment of Functioning; HAM-D, Hamilton Depression Rating Scale; IDS, Inventory for Depressive Symptoms; TPM, topiramate; YMRS, Young Mania Rating Scale.