OBJECTIVES: Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial. This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression. METHODS: Patients with bipolar Ⅱ depression were enrolled in this prospective, two-center, randomized, 12-week pilot trial. The main indicator for assessing treatment effectiveness was a Montgomery-Asberg Depression Rating Scale (MADRS) of ≥50%. All eligible patients initially received four weeks of lurasidone monotherapy. Patients who responded well continued to receive this kind of monotherapy. However, no-response patients were randomly assigned to either valproate or vortioxetine treatment for eight weeks. By comprehensively comparing the results of MADRS over a period of 4‍‒‍12 weeks, a systematic analysis was conducted to determine whether vortioxetine could be used as an adjuvant drug for treating bipolar depression. RESULTS: Thirty-seven patients responded to lurasidone monotherapy, and 60 patients were randomly assigned to the valproate or vortioxetine group for eight weeks. After two weeks of combined valproate or vortioxetine treatment, the MADRS score in the vortioxetine group was significantly lower than that in the valproate group. There was no difference in the MADRS scores between the two groups at 8 and 12 weeks. The incidence of side effects did not significantly differ between the valproate and vortioxetine groups. Importantly, three patients in the vortioxetine group appeared to switch to mania or hypomania. CONCLUSIONS This study suggested that lurasidone combination with vortioxetine might have potential benefits to bipolar II depression in the early stage, while disease progression should be monitored closely for the risk of switching to mania.
Humans ; Bipolar Disorder/drug therapy* ; Vortioxetine/therapeutic use* ; Male ; Female ; Middle Aged ; Adult ; Valproic Acid/administration & dosage* ; Lurasidone Hydrochloride/administration & dosage* ; Prospective Studies ; Treatment Outcome ; Pilot Projects ; Drug Therapy, Combination ; Sulfides/therapeutic use* ; Antidepressive Agents/therapeutic use*

Of the different phases of bipolar disorder, bipolar depression is more prevailing and is more difficult to treat. However, there is a deficit in systemic research on the pharmacological treatment of acute bipolar depression. Therefore, consensuses on the pharmacological treatment strategies of acute bipolar depression has yet to be made. Currently, there are only three drugs approved by the Food and Drug Administration for acute bipolar depression : quetiapine, olanzapine-fluoxetine complex, and lurasidone. In clinical practice, other drugs such as mood stabilizers (lamotrigine, lithium, valproate) and/or the other atypical antipsychotics (aripiprazole, risperidone, ziprasidone) are frequently prescribed. There remains controversy on the use of antidepressants in bipolar depression. Here, we summarized the evidence of current pharmacological treatment options and reviewed treatment guidelines of acute bipolar depression from recently published studies.
Antidepressive Agents ; Antipsychotic Agents ; Bipolar Disorder* ; Consensus ; Lithium ; Lurasidone Hydrochloride ; Quetiapine Fumarate ; Risperidone ; United States Food and Drug Administration