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Clinical trials for Brexpiprazole

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    34 result(s) found for: Brexpiprazole. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-002813-20 Sponsor Protocol Number: 331-201-00242 Start Date*: 2020-03-16
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
    Medical condition: Borderline Personality Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10006034 Borderline personality disorder PT
    21.1 10037175 - Psychiatric disorders 10006033 Borderline personality LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-004982-41 Sponsor Protocol Number: 14865A Start Date*: 2013-11-11
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study of brexpiprazole as adjunctive treatment to paroxetine or sertraline in adult patients suffering...
    Medical condition: Post-traumatic stress disorder (PTSD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10036316 Post-traumatic stress disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) IT (Prematurely Ended) FI (Prematurely Ended) SE (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004169-42 Sponsor Protocol Number: 14767B Start Date*: 2013-08-14
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder.
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10025461 Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior LLT
    16.0 100000004873 10025463 Major depressive disorder, single episode LLT
    16.0 100000004873 10025469 Major depressive disorder, single episode, severe degree, without mention of psychotic behavior LLT
    16.0 100000004873 10025462 Major depressive disorder, recurrent episode, unspecified degree LLT
    16.0 100000004873 10025467 Major depressive disorder, single episode, moderate degree LLT
    16.0 100000004873 10025457 Major depressive disorder, recurrent episode, mild degree LLT
    16.0 100000004873 10025458 Major depressive disorder, recurrent episode, moderate degree LLT
    16.0 100000004873 10025470 Major depressive disorder, single episode, unspecified degree LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) LT (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) FI (Prematurely Ended) SK (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended) LV (Prematurely Ended) EE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000062-22 Sponsor Protocol Number: 331-13-214 Start Date*: 2014-10-01
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization,
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults with M...
    Medical condition: Major Depressive Disorder (MDD)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003547-35 Sponsor Protocol Number: 16160A Start Date*: 2015-04-07
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, open-label, flexible-dose, long-term study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in elderly patients with major depressive disorder with a...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    18.0 100000004873 10025463 Major depressive disorder, single episode LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: EE (Completed) DE (Completed) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002705-21 Sponsor Protocol Number: 14644B Start Date*: 2013-04-04
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) EE (Completed) SK (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-002225-38 Sponsor Protocol Number: 331-201-00083 Start Date*: 2018-02-23
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects with Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002897-30 Sponsor Protocol Number: 331-201-00195 Start Date*: 2020-02-19
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder
    Medical condition: Borderline Personality Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10006034 Borderline personality disorder PT
    21.1 10037175 - Psychiatric disorders 10006033 Borderline personality LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-002252-17 Sponsor Protocol Number: 14644A Start Date*: 2013-04-04
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, randomised, double-blind, parallel-group, placebo-controlled, active-reference, flexible-dose study of brexpiprazole in patients with acute schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) EE (Completed) SK (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-000601-22 Sponsor Protocol Number: 331-201-00079 Start Date*: 2018-11-20
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole as Adjunctive Therapy in the Maintenance Treatment of ...
    Medical condition: Major depressive disorder (MDD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-002783-88 Sponsor Protocol Number: 331-201-00182 Start Date*: 2018-12-27
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheim...
    Medical condition: Agitation Associated With Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Ongoing) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2013-000503-17 Sponsor Protocol Number: 331-12-284 Start Date*: 2015-01-29
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Prematurely Ended) SI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-003948-67 Sponsor Protocol Number: 331-12-282 Start Date*: 2013-05-08
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization,Inc
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo- and Active Comparator-controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With M...
    Medical condition: Major Depressive Disorder (MDD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) FR (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000504-41 Sponsor Protocol Number: 331-12-283 Start Date*: 2013-12-10
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Country-specific protocol amendment for Germany entitled: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2012-001361-32 Sponsor Protocol Number: 14571A Start Date*: 2013-04-29
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of brexpiprazole (1 and 3 mg/day) as adjunctive treatment in el...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004873 10025461 Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior LLT
    16.1 100000004873 10025462 Major depressive disorder, recurrent episode, unspecified degree LLT
    16.1 100000004873 10025457 Major depressive disorder, recurrent episode, mild degree LLT
    16.1 100000004873 10025458 Major depressive disorder, recurrent episode, moderate degree LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) LT (Prematurely Ended) FI (Prematurely Ended) SK (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended) GB (Prematurely Ended) PL (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001447-12 Sponsor Protocol Number: 331-10-234 Start Date*: 2019-01-11
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo- and Active controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 years old) With Schizophr...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10039636 Schizophrenia simple LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) PL (Completed) BG (Prematurely Ended) FR (Ongoing) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-002222-20 Sponsor Protocol Number: 331-201-00080 Start Date*: 2018-02-23
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-001380-76 Sponsor Protocol Number: 14570A Start Date*: 2013-03-28
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose long-term study to evaluate the maintenance of efficacy and safety of 1 to 3 mg/day of brexpiprazole a...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10025461 Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior LLT
    18.0 100000004873 10025463 Major depressive disorder, single episode LLT
    18.0 100000004873 10025469 Major depressive disorder, single episode, severe degree, without mention of psychotic behavior LLT
    18.0 100000004873 10025462 Major depressive disorder, recurrent episode, unspecified degree LLT
    18.0 100000004873 10025467 Major depressive disorder, single episode, moderate degree LLT
    18.0 100000004873 10025458 Major depressive disorder, recurrent episode, moderate degree LLT
    18.0 100000004873 10025470 Major depressive disorder, single episode, unspecified degree LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) SE (Completed) FI (Completed) LT (Completed) GB (Completed) BG (Completed) IT (Prematurely Ended) LV (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002190-20 Sponsor Protocol Number: 331-201-00081 Start Date*: 2018-04-09
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HR (Completed)
    Trial results: View results
    EudraCT Number: 2014-000424-23 Sponsor Protocol Number: 331-13-211 Start Date*: 2014-10-31
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer?s Type who were Previously Treated with Brexpiprazole (OPC-34712...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SI (Completed) FR (Completed) GB (Completed) HR (Completed) BG (Completed)
    Trial results: View results
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