| Title: | An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in De Novo Subjects With DSM-5 Schizophrenia |
| Sponsor: | Karuna Therapeutics |
| Study Phase: | 3 |
| Study Sites: | Approximately 60 sites in the United States |
| Indication: | Schizophrenia |
| Primary Objective: | The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a Diagnostic and Statistical Manual-Fifth Addition (DSM-5) diagnosis of schizophrenia. |
| Title: | A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder |
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| 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) |
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| 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) |
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| 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. |
| Title: | A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy with Sertraline in the Treatment of Adults with Post-traumatic Stress Disordery |
| Sponsor: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Study Phase: | 3 |
| Indication: | Post-traumatic stress disorder (PTSD) |
| Primary Objective: | To evaluate the efficacy of brexpiprazole + sertraline in adult subjects with PTSD. |
| Title: | A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder |
| Sponsor: | Clexio Biosciences Limited |
| Study Phase: | 2 |
| Indication: | CLE-100 is being investigated as an adjunct therapy for patients with major depressive disorder (MDD) with an inadequate response to standard antidepressant therapy. |
| Primary Objective: | The study objective is to assess the safety, efficacy, and tolerability of 40 mg CLE-100 for the treatment of MDD in subjects with an inadequate response to standard antidepressant therapy. |
| Title: | A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects with Schizophrenia Treated Prospectively for 6-months with Abilify MyCite® |
| Sponsor: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Study Phase: | 3b |
| Indication: | Schizophrenia |
| Primary Objective: | To compare inpatient psychiatric hospitalization rates (proportion of subjects with ≥1 inpatient psychiatric hospitalizations) between the retrospective period (Months 1 to 3) while subjects are on oral standard-of-care antipsychotic treatment and the prospective period (Months 1 to 3) after the subjects switch to Abilify MyCite. |
| Title: | A Multi-region, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I disorder (Bipolar I Depression) |
| Sponsor: | Sunovion Pharmaceuticals Inc.; Sponsor in Japan: Sumitomo in Dainippon Pharma Co. Ltd. |
| Study Phase: | 3 |
| Study Sites: | Up to 90 sites in Europe (EUR), Japan (JP), and the United States (US) |
| Indication: | Major depressive episode associated with bipolar I disorder (bipolar I depression) |
| Primary Objective: | The objective of Study SEP380-301 is to evaluate the safety, efficacy, and tolerability of SEP-4199 CR formulation given as monotherapy at fixed doses of 200 mg/day and 400 mg/day compared with placebo in the treatment of subjects with major depressive episode associated with bipolar I disorder (bipolar I depression). |