Completed Trials - Siyan Clinical Research

Title:	A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder
Sponsor:	Siyan Clinical Corporation
Study Phase:	Phase 4
Study Type:	Interventional
Intervention:	Drug: Vortioxetine (Vortioxetine 5-20mg)
Primary Objective	The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult population with a diagnosis of PD. PD is generally treated with benzodiazepines which are very effective but have a high risk for addiction, fall, and cognitive impairment. There is still a need for better treatment for PD for longer term use. There are other drugs within the SSRI/SNRI class which have proven to be effective in treating patients with this diagnosis.

Title:	A Phase 3, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension to assess the efficacy and safety of ITI-007 monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Sponsor:	Intra-Cellular Therapies, Inc. (ITI)
Study Phase:	Phase 3
Study Sites:	Approximately 60 study sites in 1 country (United States)
Indication:	Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Primary Objective	The primary objective of Part A of this study is to compare the efficacy of 2 doses of ITI-007 administered orally once daily to that of placebo in mean change from baseline in the total score on the rater-administered Montgomery-Åsberg Depression Rating Scale (MADRS) in patients with bipolar depression at Week 6.

Title:	A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of ITI-007 monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Sponsor:	Intra-Cellular Therapies, Inc. (ITI)
Study Phase:	Phase 3
Study Sites:	Approximately 30 study sites in 1 country (United States)
Indication:	Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Primary Objective	The primary objective of this study is to compare the efficacy of 2 doses of ITI-007 administered orally once daily to that of placebo in absolute mean change from baseline in the total score on the rater-administered Montgomery-Åsberg Depression Rating Scale (MADRS) in patients with bipolar depression at Week 6.

Title:	A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ITI-007 adjunctive to lithium or valproate in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Sponsor:	Intra-Cellular Therapies, Inc. (ITI)
Study Phase:	Phase 3
Study Sites:	Approximately 30 study sites in 1 country (United States)
Indication:	Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
Primary Objective	The primary objective of this study is to compare the efficacy of 2 doses of ITI-007 adjunctive to treatment with lithium or valproate, administered orally once daily, to that of placebo adjunctive to treatment with lithium or valproate in absolute mean change from baseline in the total score of the rateradministered Montgomery-Åsberg Depression Rating Scale (MADRS) in patients with bipolar depression at Week 6.