Table 4.

Effect of V_1B Receptor Antagonists in Clinical Trials (Other Stress-related Disorders)

Compound	Trial	Dose regimen	Patients	Primary endpoint	Results	ClinicalTrial. gov identifier	Reference
SSR149415	Randomized, double-blinded, placebo-controlled study (DFI5880)	SSR149415 (100 mg, 250 mg) or placebo, BID for 8 wk (active control: paroxetine, 20 mg QD)	GAD patients SSR149415 100 mg (n = 79) SSR149415 250 mg (n = 82) placebo n = 81 paroxetine n = 82	Changes from baseline in HAM-A total score at wk 8	• Differences between placebo and each SSR149415 dose on HAM-A score were not statistically significant, while paroxetine significantly reduced HAM-A score • No statistical difference between placebo and each SSR149414 dose on secondary endpoints (CGI-S, MADRS)	NCT00374166	Griebel et al., 2012
ABT-436	Randomized, double-blinded, placebo-controlled study	ABT-436 (titrated from 200 to 800 mg) or placebo for 12 wk (wk 2–12, 400 mg BID used; 400 mg BID selected to reduce risk of drop-outs due to gastrointestinal effects)	Alcohol dependence ABT-436 n = 73 placebo n = 71	Weekly percentage of heavy drinking days	• ABT-436 group showed lower adjusted levels of percentage of heavy drinking days than placebo group, although effect was not statistically significant • ABT-436 group had significantly greater percentage of days abstinent than placebo group • No statistical difference between placebo and ABT-436 on alcohol-related craving and consequences	NCT01613014	Ryan et al., 2017

Abbreviations: CGI-S, Clinical Global Impressions-Severity of Illness Score; GAD, generalized anxiety disorder; HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery-Åsberg Depression Rating Scale.