Table 1.
Patient characteristics (safety analysis set)
| Characteristics/category | No of patients (%) |
|---|---|
| Safety analysis set | 989 |
| Gender | |
| Male | 436 (44.1) |
| Female | 553 (55.9) |
| Age (years) | |
| <15 | 2 (0.2) |
| ≥15 to <20 | 13 (1.3) |
| ≥20 to <30 | 146 (14.8) |
| ≥30 to <40 | 238 (24.1) |
| ≥40 to <50 | 255 (25.8) |
| ≥50 to <60 | 174 (17.6) |
| ≥60 to <65 | 64 (6.5) |
| ≥65 | 97 (9.8) |
| Min to max | 13–83 |
| Mean ± SD | 44.2±14.22 |
| Median | 43 |
| Diagnosis | |
| BDI | 258 (26.1) |
| BDII | 652 (65.9) |
| Cyclothymic disorder | 29 (2.9) |
| BD not otherwise specified | 41 (4.1) |
| Othera | 9 (0.9) |
| Duration of BD (years) | |
| <1 | 36 (3.6) |
| ≥1 to <2 | 46 (4.7) |
| ≥2 to <5 | 124 (12.5) |
| ≥5 to <10 | 172 (17.4) |
| ≥10 to <20 | 230 (23.3) |
| ≥20 | 118 (11.9) |
| Unknown | 263 (26.6) |
| Min to max | 0–47 |
| Mean ± SD | 11.0±9.41 |
| Median | 9 |
| No of mood episodes in the past year (times) | |
| 0 | 18 (1.8) |
| 1 | 358 (36.2) |
| 2 | 227 (23.0) |
| 3 | 88 (8.9) |
| ≥4 | 40 (4.0) |
| Unknown | 258 (26.1) |
| Min to max | 0–14 |
| Mean ± SD | 1.8±1.42 |
| Median | 1 |
| Type of mood episodes at the start of lamotrigine treatment | |
| Manic | 37 (3.7) |
| Hypomanic | 75 (7.6) |
| Mixed | 134 (13.5) |
| Major depressive | 660 (66.7) |
| Indeterminate | 17 (1.7) |
| Normal mood | 65 (6.6) |
| Unknown | 1 (0.1) |
| Severity of mood episodes at the start of lamotrigine treatment | |
| Indeterminate | 6 (0.6) |
| Normal (no symptoms) | 46 (4.7) |
| Degree to which the presence of BD cannot be denied | 26 (2.6) |
| Mild | 265 (26.8) |
| Moderate | 514 (52.0) |
| Severe | 116 (11.7) |
| Very severe | 14 (1.4) |
| Extremely severe | 2 (0.2) |
| Concomitant medication | |
| No | 64 (6.5) |
| Yes | 925 (93.5) |
| Concomitant medication (more than 1 in some cases) | |
| Mood stabilizer | 468 (47.3) |
| Lithium | 303 (30.6) |
| Sodium valproate | 188 (19.0) |
| Carbamazepine | 40 (4.0) |
| Concomitant antipsychotic | 542 (54.8) |
| Antipsychotic (atypical) | 460 (46.5) |
| Antipsychotic (typical) | 150 (15.2) |
| Concomitant antidepressant | 467 (47.2) |
| SSRI/SNRI/NaSSA | 432 (43.7) |
| Tricyclic/tetracyclic | 101 (10.2) |
Note:
a
Depression (n=2), affective disorder (n=1), schizophrenia (n=1), schizoaffective disorder (n=1), Cotard’s syndrome (n=1), adjustment disorder (n=1), acute and transient psychotic disorder (n=1), organic systemic disorders due to late effects of cerebral infarction (n=1).
Abbreviations: SD, standard deviation; BD, bipolar disorder; BDI, bipolar I disorder; BDII, bipolar II disorder; SSRI, selective serotonin reuptake inhibitors; SNRI, serotonin–norepinephrine reuptake inhibitors; NaSSA, noradrenergic and specific serotonergic antidepressant; No, number.