Table 1.
Baseline characteristics of the patients included in the study
| Included set N = 28 | Agomelatine + valproate group N = 17 (60.7%) | Agomelatine + lithium group N = 11 (39.3%) | F or χ2 (df = 2) | P | |
|---|---|---|---|---|---|
| Sex F/M | 17/11 | 9/8 | 8/3 | 0.295 (1) | ns |
| Age in years, | 41.29 ± 13.60 | 41.94 ± 13.94 | 40.27 ± 13.66 | 0.174 | ns |
| Mean (SD); (range) | (21–64) | (23–64) | (21–61) | ||
| Age at first diagnosis of BD, | 26.21 ± 9.79 | 25.58 ± 7.68 | 27.18 ± 12.76 | 1.539 (26) | ns |
| mean (SD); (range) | (13–59) | (13–42) | (14–59) | ||
| BMI score, mean (SD) | 25.33 ± 2.62 | 25.17 ± 2.85 | 25.59 ± 2.33 | 0.610 (26) | ns |
| Positive family history for BD-II, N (%) | 10 (35.7%) | 6 (60%) | 4 (40%) | 0.003 (1) | ns |
| First episode polarity (depressive/hypomanic) | 24 (85.7%)/4 (14.3%) | 14 (82.4%)/3 (17.6%) | 10 (90.9%)/1 (9.1%) | 0.399 (1) | ns |
| Reported number of depressive | None, N = 16 (57.1%) | None, N = 9 (52.9%) | None, N = 7 (63.9%) | 0.591 (2) | ns |
| episodes (previous 5 years)* | ≤3, N = 10 (35.7%) | ≤3, N = 7 (41.2%) | ≤3, N = 3 (27.3%) | ||
| ≥4, N = 2 (7.1%) | ≥4, N = 1 (5.9%) | ≥4, N = 1 (9.1%) | |||
| Duration of current depressive | 25.64 ± 18.54; (14–90) | 26.18 ± 21.59; (14–90) | 24.82 ± 13.47; (14–60) | 10.781 (10) | ns |
| episode days (SD); (range) | |||||
| HAM-D-17 score (SD); (range) | 25.86 ± 3.19; (19–31) | 26.53 ± 2.76; (21–31) | 24.82 ± 3.65; (19–31) | 14.374 (10) | ns |
| YMRS score (SD) | 3.544 (6) | ns | |||
| PSQI score (SD) | 11.39 ± 5.31 | 10.70 ± 4.62 | 12.45 ± 6.33 | 12.453 (12) | ns |
| CGI-BP-S (SD) | 4.36 ± 1.37 | 3.94 ± 1.14 | 5 ± 1.48 | 5.372 (6) | ns |
| Lifetime axis-I co-morbidity, N (%) | |||||
| Generalized anxiety disorder | 6 (21.4%) | 4 (23.5%) | 2 (18.2%) | 0.113 (1) | ns |
| Obsessive-compulsive disorder | 7 (25%) | 3 (17.6%) | 4 (36.4%) | 1.248 (1) | ns |
| Panic disorder | 5 (17.9%) | 3 (17.6%) | 2 (18.2%) | 0.001 (1) | ns |
| Specific phobias | 8 (26.6%) | 4 (23.3%) | 4 (36.4%) | 0.539 (1) | ns |
| Impulse control disorder | 4 (14.3%) | 3 (17.6%) | 1 (9.1%) | 0.399 (1) | ns |
| Anorexia nervosa | 1 (3.6%) | 1 (5.9%) | 0 | 0.671 (1) | ns |
| Bulimia nervosa | 3 (10.7%) | 2 (11.8%) | 1 (9.1%) | 0.050 (1) | ns |
| Binge eating disorder | 4 (14.3%) | 3 (17.6%) | 1 (9.1%) | 0.399 (1) | ns |
Notes: For χ2 and relative, P-values refer to the comparison between the two groups, not versus the whole sample (+valproate vs +lithium). “Age at first diagnosis of BD” may differ from age at first medical consultation for major depression or from actual age of onset of BD.
*
Current MDE excluded.
Abbreviations: BMI, body mass index; CGI-BP-I/S, Clinical Global Impression/Severity scales for Bipolar Disorder; HAM-D-17, Hamilton Depression Rating-Scale 17-item; MDE, major depressive episode; PSQI, Pittsburgh Sleep Quality Index; SD, standard deviation; YMRS, Young Mania Rating Scales.