Cariprazine’s efficacy in treating depressive symptoms – pooled data from schizophrenia, bipolar depression and major depression trials

Introduction Depressive symptoms are a common feature of schizophrenia (SCH) and define bipolar disorder major depressive (MDD). Their emergence is related to altered neurotransmission at the serotonin receptors potentially dopamine D3 receptors. Objectives The aim this analysis was examine efficacy cariprazine (CAR) in treating SCH, depression (BD) MDD. Methods Clinical trials with randomised, double-blind, placebo (PLB)-controlled designs were included these analyses. Data from 3 SCH [NCT00694707, NCT01104766, NCT01104779; 1.5-9 mg/d] BD [NCT01396447, NCT02670538, NCT02670551; 1.5-3 studies pooled. In MDD, add-on CAR antidepressant treatment evaluated against PLB two [NCT03738215: 1.5 mg/d; NCT01469377: 1-2 mg/d 2-4.5 mg/d). Least square (LS) mean changes analysed using Mixed Model Repeated Measures: baseline (BL) Week 6 Positive Negative Syndrome Scale (PANSS)-derived Marder anxiety/depression factor items (schizophrenia); BL Montgomery-Åsberg Depression Rating (MADRS) total scores (bipolar depression); [NCT03738215] 8 [NCT01469377] MADRS score (major disorder). Results Altogether, 1466 (PLB=442, CAR=1024) patients pooled analysis. analysis, data 1383 (PLB=460, CAR=923) MDD trials, there 502 (1.5mg/d=250, mg/d=252) 249 PLB-treated [NCT03738215], 544 (1-2 mg/d=273, mg/d=271) 264 other study [NCT01469377]. achieved significantly greater reductions than on domain (LS change: PLB= -2.66, CAR= -3.26, p<0.01): effect driven by out 4 items. BD, yielded improvement compared -12.05, -14.69, p<0.001), which 9 10 alleviated -11.5, 1.5mg/d= -14.1, p<0.01), while trial [NCT01469377], produced -12.5, mg/d= -14.6, p<0.01). Conclusions These findings indicate that an effective option for independent disease (in MDD), being transdiagnostic broad-spectrum option. Disclosure Interest R. McIntyre Grant / Research support from: CIHR/GACD/National Natural Science Foundation China (NSFC), Milken Institute, Consultant of: Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, Gedeon Richter, Recordati, Atai Life Sciences, Speakers bureau Csehi Employee Richter Plc., G. Németh Plc.