A 40-week double-blind aripiprazole versus lithium follow-up of a 12-week acute phase study (total 52 weeks) in bipolar I disorder

Background tudy followed manic or mixed bipolar I subjects for an additional 40 weeks after initial randomization to 12 weeks of lithium versus aripiprazole monotherapy. This is the only long-term, double-blind study comparing lithium and aripiprazole. s ts continued receiving either aripiprazole 15 or 30 mg/day, or lithium 900, 1200 or 1500 mg/day in a double-blind fashion for 40 weeks after completing a 12-week double-blind study (52 weeks total treatment). Efficacy endpoints included adjusted mean change from baseline to Week 52 in Young Mania Rating Scale (YMRS) total score and Montgomery–Åsberg Depression Rating Scale (MADRS) total scores (observed cases). Remission was defined as YMRS total score ≤ 12. Safety and tolerability were also assessed. s 66 patients who entered the extension phase, only 20 patients (30.3%) completed the entire phase (aripiprazole n = 7; lithium n = 13). The significant improvement that occurred over the first 12 weeks was maintained over the 40 weeks of blinded continuation (from Week 12 through Week 52). The most common treatment-emergent adverse events in the extension phase for aripiprazole were akathisia, headache, somnolence, anxiety and nasopharyngitis (all 8%), and for lithium were insomnia (15.8%), headache (13.2%), diarrhea (13.2%) and vomiting (10.5%). Mean weight change was + 2.71 kg for lithium and + 5.66 kg for aripiprazole (p = 0.46). tions rial was not powered to statistically compare active treatments, and long-term completion rates were low in both groups. sions razole monotherapy appears to be equivalently useful to lithium for the extended treatment of mixed or manic bipolar disorder patients.