Comparing Lamotrigine versus Lithium efficacy, tolerability, safety in treatment of BPD II.

30 female patients,19–60 years old, diagnosed with BPD II according to DSM IV-TR criteria, were enrolled in the study for 24 weeks. HAM-D ≥ 18 and Y-MRS ≤ 10 were used to diagnose depression and hypomania; CGI for severity and improvement. 28 patients analyzed for efficacy, 30 patients for safety. Response to treatment was defined the reduction 50% of values from starting point measured by HAM-D, Y-MRS, CGI-I for values < 2. Remission considered HAM-D ≥ 7, patients were evaluated on week 12 and 24. Paroxetine and lorazepam were used. Time,dose were compared between two parallel groups. Statistical analysis evaluated through Student test (X2) and Z test variable changes on week 0;12;24

After statistical analysis on validity of comparison considering numbers of past episodes,type of actual episode and age, the groups were comparable without significant statistical differences. Lamotrigine and Lithium showed significant efficacy on BP-II ((p = 0.001). They resulted equal efficacious in the treatment of depression and hypomania, for response and remission rate. Was not statistical significant difference between groups on week 8(p = 0,787), 12 (p = 0,124) and 24 (p = 0,348) for Y-MRS, reflecting comparable efficacy on hypomania symptoms. On week 12 six patients(21.2%) resulted in remission with lamotrigine and four (14.3%)with lithium. Statistical analysis showed no difference for dose and time for paroxetine (p = 0.953);(p = 0.701) and lorazepam (p = 0.937);(p = 0.411). Lamotrigine has higher tolerability rate. Side effects prevalence during study period was 12.5% for lamotrigine and 57.14% for lithium groups.

Lamotrigine and lithium resulted equally efficacious for both episodes of BP-II during acute and maintenance treatment. Lamotrigine manifested less side effects, better compliance.