Key Takeaways
Extended Takeaways
- Quetiapine separated from placebo by week 1 on both MADRS and HARS, supporting its use when early improvement in depressive and anxiety symptoms is clinically important during an acute bipolar depression episode.
- Lithium dosing achieved a mean median serum concentration of 0.61 mEq/L, and even the subgroup with median serum lithium concentrations ≥ 0.8 mEq/L showed no significant advantage over placebo on MADRS total score at week 8 (difference of -2.76 points at week 8; P = .128).
- At week 8, response and remission rates with quetiapine were 68.6% and 69.8% for 300 mg/d and 69.6% and 70.3% for 600 mg/d, versus 55.8% and 55.0% for placebo, yielding NNTs of 8 and 7 for response and 7 and 7 for remission.
- Quetiapine 600 mg/d outperformed lithium on several symptom domains, including MADRS total score at week 8 (difference of -2.49 points at week 8, P = .013), HDRS total score (difference, -1.81; P = .026), and HARS, suggesting broader acute benefit than lithium monotherapy in bipolar depression.
- Functional gains were more evident with quetiapine than lithium: by week 8, quetiapine 600 mg/d significantly improved both SDS total score (P < .01) and MOS-Cog total score (P = .01) versus placebo, while quetiapine 300 mg/d significantly improved SDS total score (P < .05).
- Tolerability tradeoffs were clinically distinct: discontinuation due to adverse events was 10.4% with quetiapine 300 mg/d and 13.9% with quetiapine 600 mg/d versus 8.8% with lithium and 8.4% with placebo, while treatment-emergent suicidal ideation remained low across groups and was highest with placebo at 2.3%.
