Table 1

Summary of FDA-approved medications for bipolar depression

Pharmacological agentYear approvedCommon adverse effectsEffectiveness
Olanzapine + fluoxetine2003
  • Weight gain

  • Nausea

  • Diarrhoea

  • Diabetes

  • Dyslipidaemia

  • Cardiovascular disease

  • OFC therapy significantly reduced the severity of depressive symptoms when compared with a placebo (OR: 0.38, 95% CI: 0.24 to 0.59).

  • OFC therapy also reduced relapse rate (NNT=5).

Quetiapine2008
  • Sedation

  • Extrapyramidal symptoms

  • Dizziness

  • Fatigue

  • Constipation

  • Weight gain

  • Quetiapine significantly decreased Clinical Global Impression-Severity scores or Clinical Global Impression for Bipolar Severity of Illness scores (mean difference=−4.66, 95% CI: −5.59 to −3.73).

Lurasidone2013
  • Akathisia

  • Somnolence

  • Extrapyramidal symptoms

  • Lurasidone is described as having similar efficacy in mitigating depressive symptoms with similar overall effect sizes compared with OFC and quetiapine.

Cariprazine2019
  • Insomnia

  • Extrapyramidal symptoms

  • Nausea

  • Sedation

  • Dizziness

  • Constipation

  • Cariprazine is associated with a small but significant reduction in depression symptoms, as assessed by the MADRS (standard mean difference: −0.26, 95% CI: −0.49 to −0.02).

Lumateperone2021
  • Sedation

  • Nausea

  • Dizziness

  • Dry mouth

  • Lumateperone had significantly greater MADRS response rate (51.1% vs 36.7%; OR=2.98, p<0.001) and remission rate (p=0.02) compared with placebo.

  • CI, confidence interval; FDA, Food and Drug Administration; MADRS, Montgomery-Asberg Depression Rating Scale; NNT, needed to treat; OFC, olanzapine plus fluoxetine; OR, odds ratio.