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In 2009, quetiapine XR was approved as adjunctive treatment of major depressive disorder. [97] Quetiapine received its initial approval from the US FDA for the treatment of schizophrenia in 1997. [4] [98] In 2004, it received its second indication for the treatment of mania-associated bipolar disorder. [99]
Levosulpiride – approved in low doses for major depressive disorder [11] Lumateperone (Caplyta) – approved as a monotherapy for bipolar depression; Lurasidone (Latuda) – approved as a monotherapy for bipolar depression; Quetiapine (Seroquel) – approved as a monotherapy for bipolar depression
whereas only quetiapine has demonstrated efficacy as a monotherapy in non-psychotic MDD. [40] Olanzapine/fluoxetine is an efficacious treatment in both psychotic and non-psychotic MDD. [41] [42] Aripiprazole, brexpiprazole, cariprazine, olanzapine, and quetiapine have been approved as adjunct treatment for MDD by the FDA in the United States.
Variations in the indication of a drug may differ between two regions. Based on table 2, there is a broader indication of Olanzapine use in the US. [26] It is approved for treatment-resistant depression and agitation besides of bipolar and Schizophrenia. Whereas in UK, it is only for bipolar and schizophrenia. [27]
Lumateperone was approved for medical use in the United States in December 2019 with an initial indication for schizophrenia, [4] [5] and became available in February 2020. [2] It has since demonstrated efficacy in bipolar depression and received FDA approval in December 2021 for depressive episodes associated with both bipolar I and II disorders.
[63] [64] Aripiprazole, quetiapine extended-release, and olanzapine (when used in conjunction with fluoxetine) have received the Food and Drug Administration (FDA) labelling for this indication. [65] There is, however, a greater risk of side effects with their use compared to using traditional antidepressants. [63]
Lurasidone was first approved for medical use in the United States in 2010. [2] In 2013, it was approved in Canada and by the U.S. Food and Drug Administration (FDA) to treat bipolar depression, either as monotherapy or adjunctively with lithium or valproate.
Lithium Lithium is the "classic" mood stabilizer, the first to be approved by the US FDA, and still popular in treatment. Therapeutic drug monitoring is required to ensure lithium levels remain in the therapeutic range: 0.6 to 0.8 or 0.8–1.2 mEq/L (or millimolar).
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