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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002705-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To determine the safety and efficacy of brexpiprazole during long-term treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of treatment-emergent adverse events (TEAEs) | Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US010 | Anaheim | California | United States | |||
| US020 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35235720 | Derived | Correll CU, He Y, Therrien F, MacKenzie E, Meehan SR, Weiss C, Hefting N, Hobart M. Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. J Clin Psychiatry. 2022 Mar 1;83(2):20m13793. doi: 10.4088/JCP.20m13793. | |
| 34901863 | Derived | Marder SR, Meehan SR, Weiss C, Chen D, Hobart M, Hefting N. Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies. Schizophr Bull Open. 2021 May 1;2(1):sgab014. doi: 10.1093/schizbullopen/sgab014. eCollection 2021 Jan. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole | Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cerritos |
| California |
| United States |
| US009 | Escondido | California | United States |
| US022 | Garden Grove | California | United States |
| US018 | Long Beach | California | United States |
| US011 | San Diego | California | United States |
| US021 | Washington D.C. | District of Columbia | United States |
| US004 | Kissimmee | Florida | United States |
| US015 | North Miami | Florida | United States |
| US019 | Lake Charles | Louisiana | United States |
| US016 | St Louis | Missouri | United States |
| US002 | Cedarhurst | New York | United States |
| US005 | Charleston | South Carolina | United States |
| US003 | Austin | Texas | United States |
| US012 | Austin | Texas | United States |
| US001 | Dallas | Texas | United States |
| US013 | Dallas | Texas | United States |
| EE002 | Pärnu | Estonia |
| EE001 | Tallinn | Estonia |
| PL002 | Choroszcz | Poland |
| PL005 | Choroszcz | Poland |
| PL004 | Gdansk | Poland |
| RO004 | Brasov | Romania |
| RO007 | Bucharest | Romania |
| RO011 | Bucharest | Romania |
| RO012 | Bucharest | Romania |
| RO010 | Iași | Romania |
| RO006 | PiteÅŸti | Romania |
| RU001 | Arkhangelsk | Russia |
| RU008 | Moscow | Russia |
| RU015 | Rostov-on-Don | Russia |
| RU004 | Saint Petersburg | Russia |
| RU005 | Saint Petersburg | Russia |
| RU013 | Saint Petersburg | Russia |
| RU002 | Saratov | Russia |
| RS001 | Belgrade | Serbia |
| RS003 | Belgrade | Serbia |
| RS002 | Kragujevac | Serbia |
| RS004 | Novi Kneževac | Serbia |
| SK001 | Liptovský Mikuláš | Slovakia |
| UA012 | Dnipropetrovsk | Ukraine |
| UA004 | Geikivka | Ukraine |
| UA007 | Hlevakha | Ukraine |
| UA005 | Kherson | Ukraine |
| UA008 | Kyiv | Ukraine |
| UA009 | Lviv | Ukraine |
| UA002 | Smila | Ukraine |
| UA003 | Vinnytsia | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole | Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability | Number of treatment-emergent adverse events (TEAEs) | 210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients | Posted | Number | TEAEs | Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) |
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Baseline to end of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole | 210 were enrolled, only 209 patients were treated with brexpiprazole | 31 | 209 | 47 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Lung carcinoma cell type unspecified stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment | 210 were enrolled, only 209 patients were treated with brexpiprazole, where 112 were women |
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| Aggression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Social stay hospitalisation | Social circumstances | MedDRA 16.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| Slovakia |
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| Serbia |
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| Russian Federation |
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| Estonia |
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| Poland |
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| Romania |
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