| Vraylar (cariprazine) / Mitsubishi Tanabe, Recordati, Gedeon Richter, AbbVie |
2018-004590-27: Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia |
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| Completed | 3 | 300 | Europe | cariprazine, RGH-188, Capsule, hard, Reagila | Gedeon Richter Plc, Gedeon Richter Plc | Adolescent patient (13-<18 years of age) with Schizophrenia, Adolescent patient (13-<18 years of age) with Schizophrenia, Diseases [C] - Nervous System Diseases [C10] | | | | |
2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 years of age) with Schizophrenia |
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| Ongoing | 3 | 330 | Europe | cariprazine, RGH-188, Capsule, hard | Allergan Ltd, Allergan Ltd. | Adolescent Patients (13 to 17 years of age) with Schizophrenia, Adolescent Patients (13 to 17 years of age) with Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
| Completed | 3 | 323 | US, RoW | Cariprazine, Placebo | Forest Laboratories, Gedeon Richter Ltd. | Bipolar Disorder, Mania | 07/11 | 07/11 | | |
NCT01058668: Safety and Efficacy of Cariprazine for Bipolar I Disorder |
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| Completed | 3 | 497 | US, Europe, RoW | Cariprazine, Placebo | Forest Laboratories, Gedeon Richter Ltd. | Mania, Bipolar I Disorder | 12/11 | 12/11 | | |
NCT01104779: Safety and Efficacy of Cariprazine in Schizophrenia |
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| Completed | 3 | 446 | US, RoW | Cariprazine, RGH-188, Placebo | Forest Laboratories, Gedeon Richter Ltd. | Schizophrenia | 12/11 | 12/11 | | |
NCT01104766: Safety and Efficacy of Cariprazine in Patients With Schizophrenia |
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| Completed | 3 | 617 | US, Europe, RoW | Cariprazine, RGH-188, Aripiprazole, Placebo | Forest Laboratories, Gedeon Richter Ltd. | Schizophrenia | 12/11 | 12/11 | | |
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| Completed | 3 | 403 | US, Europe | Cariprazine, RGH-188 | Forest Laboratories, Gedeon Richter Ltd. | Bipolar I Disorder | 02/12 | 02/12 | | |
| Completed | 3 | 752 | Europe, US, RoW | Cariprazine, RGH-188 | Forest Laboratories, Gedeon Richter Ltd. | Schizophrenia | 01/13 | 01/13 | | |
| Completed | 3 | 765 | US, Europe, RoW | Placebo, Cariprazine, RGH-188 | Forest Laboratories, Gedeon Richter Ltd. | Schizophrenia | 09/14 | 09/14 | | |
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2012-005485-36: A Randomized, Double-blind, Parallel-group Study to Investigate the Efficacy, Safety and Tolerability of Cariprazine in Patients with Predominant Negative Symptoms of Schizophrenia |
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| Completed | 3 | 420 | Europe, RoW | Cariprazine, Risperdal, Capsule, hard, Risperdal | Gedeon Richter Plc, Gedeon Richter Plc | Patients with Predominant Negative Symptoms of Schizophrenia, Patients with Predominant Negative Symptoms of Schizophrenia, Psychiatry and Psychology [F] - Mental Disorders [F03] | | 11/14 | | |
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NCT01838876: Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder |
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| Completed | 3 | 442 | US | Cariprazine, Antidepressant Therapy (ADT) | Forest Laboratories, Gedeon Richter Ltd. | Major Depressive Disorder | 07/15 | 07/15 | | |
NCT01715805: Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) |
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| Completed | 3 | 1022 | US | Cariprazine, Placebo, Antidepressant Therapy (ADT) | Forest Laboratories, Gedeon Richter Ltd. | Major Depressive Disorder | 06/16 | 06/16 | | |
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NCT02670551 / 2016-000757-13: Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression |
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| Completed | 3 | 488 | US, Europe | Cariprazine, VRAYLAR®, Placebo | Forest Laboratories | Bipolar Disorder, Depression | 07/17 | 07/17 | | |
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NCT02670538 / 2016-000756-98: Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder |
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| Completed | 3 | 493 | US, Europe, RoW | Cariprazine, Vraylar, Placebo | Forest Laboratories | Bipolar Disorder, Depression | 01/18 | 01/18 | | |
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NCT03593213: Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia |
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| Terminated | 3 | 587 | Europe, US, RoW | Cariprazine, Placebo | AbbVie | Schizophrenia | 02/21 | 02/21 | | |
NCT03739203: The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone |
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| Completed | 3 | 752 | Europe, Canada, US, RoW | Cariprazine, VRAYLAR®, Placebo, Antidepressant Therapy (ADT) | AbbVie | Major Depressive Disorder | 09/21 | 09/21 | | |
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2018-003164-31: The purpose of this study is to look into the safety and efficacy ofcariprazine as an add-on medication in the treatment of major depressivedisorder. |
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| Completed | 3 | 750 | RoW, Europe | Cariprazine, Capsule | Allergan Ltd., Allergan Sales LLC | Major Depressive Disorder, Clinical Depression, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
NCT03738215 / 2018-002782-19: Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone |
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| Completed | 3 | 759 | Europe, US, RoW | Cariprazine, Placebo | AbbVie | Major Depressive Disorder | 09/21 | 09/21 | | |
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NCT04519099 / 2017-000818-34: Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia |
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| Recruiting | 3 | 345 | Europe, US, RoW | Cariprazine, Placebo | Allergan, Allergan Ltd | Schizophrenia | 04/22 | 04/22 | | |
NCT03573297 / 2017-000803-25: A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features |
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| Completed | 3 | 901 | Europe, US, RoW | Cariprazine, Placebo | AbbVie | Bipolar I Disorder, Mania, Depression | 09/22 | 09/22 | | |
NCT05168007: Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia |
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| Enrolling by invitation | 3 | 342 | RoW | WID-RGC20(Cariprazine) 3mg/day, WID-RGC20(Cariprazine) 6mg/day, Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day | Whanin Pharmaceutical Company | Schizophrenia | 07/23 | 07/23 | | |
NCT05439616: Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD |
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| Completed | 3 | 161 | US | Cariprazine, VRAYLAR, AGN-241780, Placebo | AbbVie | Autism Spectrum Disorder | 10/24 | 10/24 | | |
NCT04777357: A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. |
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| Recruiting | 3 | 380 | US, RoW | Cariprazine, Vraylar, Placebo | AbbVie | Depression, Bipolar I Disorder | 03/27 | 03/27 | | |
NCT03817502 / 2018-004006-26: Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia |
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| Recruiting | 3 | 330 | Europe, US, RoW | Cariprazine, Placebo | Gedeon Richter Plc., Allergan Ltd. | Schizophrenia | 12/26 | 12/26 | | |
NCT05368558: Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia |
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| Terminated | 3 | 34 | Japan, RoW | Cariprazine, VRAYLAR, Placebo | AbbVie | Schizophrenia | 09/24 | 09/24 | | |
NCT04578756: Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder |
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| Completed | 3 | 310 | US | Cariprazine Flexible Dose | AbbVie | Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD) | 10/25 | 10/25 | | |
| Terminated | 3 | 1 | Canada | Cariprazine, VRAYLAR®, Placebo | Lakshmi N Yatham | Bipolar I Disorder, Cognitive Impairment | 09/24 | 09/24 | | |
NCT01626859: A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia |
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| Completed | 2/3 | 38 | Japan | MP-214 3mg, MP-214 6mg, MP-214 9mg | Tanabe Pharma Corporation | Schizophrenia | 08/13 | 08/13 | | |
NCT01626885: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia |
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| Completed | 2/3 | 42 | Japan | MP-214 | Tanabe Pharma Corporation | Schizophrenia | 06/14 | 06/14 | | |
NCT01625897: A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia |
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| Completed | 2/3 | 125 | Japan | MP-214, Risperidone | Tanabe Pharma Corporation | Schizophrenia | 03/15 | 03/15 | | |
NCT01625000: Safety and Efficacy of MP-214 in Patients With Schizophrenia |
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| Completed | 2/3 | 512 | Japan, RoW | MP-214 3mg, MP-214 6mg, MP-214 9mg, Risperidone 4mg, Placebo | Tanabe Pharma Corporation | Schizophrenia | 08/15 | 10/15 | | |
NCT01626872: Long-Term Study of MP-214 in Patients With Schizophrenia |
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| Completed | 2/3 | 254 | Japan, RoW | MP-214 3mg, MP-214 6mg, MP-214 9mg, Risperidone 4mg | Tanabe Pharma Corporation | Schizophrenia | 10/16 | 10/16 | | |
