• Antiepileptics drugs
• Bipolar disorder I
• Bipolar disorder II
• Lithium Salts
• Mood stabilizer

Bipolar disorder (BD) is a chronic mood disorder characterized by recurrent manic, hypomanic, depressive and mixed episodes. The main goal of maintenance treatment of bipolar disorder is stabilizing mood and reducing inter-episodic symptoms. Lithium salts are the gold standard for acute and long-term management of bipolar disorder because of its prophylactic and antisuicidal properties. The aim of our prospective naturalistic study was to examine the clinical characteristics and the course of illness in a sample of 234 BD-I or BD-II outpatients treated with lithium salts or anti-epileptics drugs or with a combination of both. We studied a possible relationship between the kind of stabilization utilized and the characteristics of illness. Patients have been followed for a period of at least 8 months at Section of Psychiatry, Department of Clinical and Experimental Medicine, University of Pisa and at the Istituto di Psicopatologia in Rome. Patient enrollment criteria were age 18-65 years and meeting DSM IV criteria for BD-I or BD-II or Koukopoulos’s criteria for mixed attenuated episodes. We used the SCID-I / P, SIMD and the LIFE scale to evaluate the diagnostic, clinical and therapeutic aspects. We divided the 234 patients into three groups according to the different treatments utilized for long term stabilization of Bipolar disorder: 51 patients with Lithium only, 56 patients stabilized with anticonvulsant drugs and 127 patients stabilized with a combination of Lithium and anticonvulsant drugs. Our study highlights that Lithium and antiepileptic drugs combination was the most common treatment strategy used to stabilize patients in the sample.
From our findings, patients taking lithium and anti-epileptics combination were more frequently affected by BD-I, had higher rates of mixed episodes in retrospective and prospective course, higher rates of lifetime psychotic symptoms, and showed higher rates of concomitant atypical antipsychotic prescription. Patients stabilized with anti-epileptics or lithium alone were more frequently BD-II, had higher rate of comorbidity and higher antidepressants concomitant prescription.
No significant difference emerged according to the duration of the follow up period among the three groups of treatment, so that we could suppose the long-term tolerance of lithium associated with anti-epileptic drugs was similar to the tolerability expected by using a single mood stabilizer. Overall, in our study, patients on a combination therapy, had evidenced the major improvement measured as the difference between the medium frequency of relapses in retrospective and prospective course, rather than the other patients treated on a single mood stabilizer.
Several limitations in the present study should be considered.
The most important are its small sample, the lack of randomization and the absence of a placebo group which not permitted to evaluate and draw conclusions about the efficacy of the treatments. Further investigations are required to confirm the present study's results.