The authors note that, due to the adverse effects of OFC (eg, metabolic syndrome), “clinicians should weigh the risk of therapy against the benefits.” Behavioral interventions to improve nutrition and reverse sedentary lifestyle should be included in the treatment plan.1

Quetiapine: The FDA approved quetiapine on the basis of four randomized controlled trials (RCTS): BOLDER I (n=542); BOLDER II (n=509); EMBOLDEN I (n=802), and EMBOLDEN II (n=740). In all four trials, immediate-release quetiapine (at 300mg/day or 600mg/day) improved the MADRS score from baseline in patients with BPADI or BPADII. Neither dose seemed superior to the other.11-14

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An extended-release (XR) formulation of quetiapine as monotherapy was approved by the FDA on the basis of an eight-week RCT, which randomized patients with BPADI and BAPDII and a MADRS total score of ≥20 to receive a fixed dose of quetiapine XR (n=133) or placebo (n=137). The change in MADRS total score from baseline was significantly greater in the treatment group as early as one week into the trial (P<0.001) and remained significant at the conclusion of the trial (P<0.001). There was no significant difference between treatment-emergent mania in the two groups.15 Adverse effects included increased appetite, sedation, somnolence, and dry mouth. Notably, a weight gain of ≥ 7% from baseline occurred more frequently in the treatment group (8.2% vs 0.8%). The quetiapine group also experienced higher mean changes in hemoglobin A1c and triglycerides.15 The authors note that the true rates of these side effects may actually be higher than the rates reported in the trial, due to the brief eight-week follow-up period, “underscoring the importance of long-term monitoring.”1

Lurasidone: FDA approval for lurasidone monotherapy in bipolar depression was based on results of the PREVAIL I and PREVAIL II studies. In PREVAIL I, which studied lurasidone as adjunctive therapy, patients with BPADI depression were stratified according to their mood stabilizer (ie, lithium or valproate) and randomized to receive placebo (n=165) or lurasidone (n=183) for six weeks. The change in MADRS total score from baseline was significantly greater in the lurasidone than in the placebo group (P=0.005). Treatment-emergent mania was similar between the two groups.16

In PREVAIL II, patients with BPADI were randomized to received low-dose lurasidone monotherapy (n=166), high-dose lurasidone monotherapy (n=169), or placebo (n=170). Both treatment groups experienced greater reduction in MADRS total score from baseline, as compared to placebo (P<0.001 for each group). Treatment-emergent mania was more frequent in the low-dose lurasidone group than in the high-dose or placebo groups (3.8% vs 1.9% and 1.9%).17

The most common side effects for lurasidone were nausea, somnolence, tremor, akathisia, insomnia, and headache.16,17