Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Brief Summary: The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.


Options:
A: Arm Label: Intranasal Esketamine 84mg plus Oral Antidepressant; Type: EXPERIMENTAL; Interventions: Drug: Esketamine, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Arm Label: Esketamine 56 mg plus Oral Antidepressant; Type: EXPERIMENTAL; Interventions: Drug: Esketamine, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Arm Label: Placebo plus Oral Antidepressant; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Intervention Type: DRUG; Name: Esketamine; Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Duloxetine (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Escitalopram (Oral antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Sertraline (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Venlafaxine Extended Release (XR) (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant
B: Arm Label: Esketamine low dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - low dose | Arm Label: Esketamine medium dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - medium dose | Arm Label: Esketamine high dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - high dose | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo DPI | Intervention Type: DRUG; Name: Esketamine DPI - low dose; Assigned to Arm(s): Esketamine low dose | Intervention Type: DRUG; Name: Esketamine DPI - medium dose; Assigned to Arm(s): Esketamine medium dose | Intervention Type: DRUG; Name: Esketamine DPI - high dose; Assigned to Arm(s): Esketamine high dose | Intervention Type: DRUG; Name: Placebo DPI; Assigned to Arm(s): Placebo
C: Arm Label: Ketamine, Then Placebo; Type: EXPERIMENTAL; Interventions: Drug: Ketamine, Drug: Placebo | Arm Label: Placebo, Then Ketamine; Type: EXPERIMENTAL; Interventions: Drug: Ketamine, Drug: Placebo | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Ketamine, Then Placebo, Placebo, Then Ketamine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ketamine, Then Placebo, Placebo, Then Ketamine
D: Arm Label: Ketamine; Type: EXPERIMENTAL; Interventions: Drug: Ketamine | Arm Label: Propofol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Propofol | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Ketamine | Intervention Type: DRUG; Name: Propofol; Assigned to Arm(s): Propofol

Answer: B