Table 1 Study Inclusion and Exclusion Criteria

Patient population

Adults (> 18 years old) with bipolar depression where at least 50% of the population were diagnosed with bipolar I disorder

•< 50% bipolar I disorder

•< 18 years old

Interventions

Atypical antipsychotic monotherapy:

•Cariprazine¹

•Lurasidone

•Quetiapine

•Olanzapine

•Aripiprazole

•Asenapine

•Risperidone

•Ziprasidone

•Brexpiprazole¹

•Lumateperone¹

•All other atypical antipsychotic monotherapies assessed for the treatment of bipolar I depression²

•Any treatments other than those listed in the inclusion criteria

•Any treatments listed in inclusion criteria if administered as adjunctive therapy

Comparators

Any of the above listed interventions or placebo

Comparators other than those listed in the inclusion criteria

Outcomes

Studies reporting at least one of the following outcomes:

•Change from baseline in MADRS

•Change from baseline in CGI-BP-S

•Response (defined as ≥50% improvement inMADRS)

•Remission (defined as MADRS score ≤ 12 and ≤ 10at endpoint)

•≥ 7% weight gain

•Change from baseline in weight

•Change from baseline in glucose level

•Change from baseline in low-density lipoprotein (LDL)

•Change from baseline in total cholesterol

•Change from baseline in triglycerides

•Change from baseline in prolactin

•Akathisia

•Extrapyramidal symptoms

•Somnolence

•All-cause discontinuation

•Discontinuation due to lack of efficacy

•Discontinuation due to adverse events

•Switch to mania³

Studies not reporting least one of the outcomes included in the inclusion criteria.

Study design

Randomized controlled trials

•Non-randomized controlled trials

•Observational studies

•Case studies

•Pharmacology studies