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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.5 mg, Brexpipraxzole (OPC-34712) |
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| Cohort 2 | Experimental | 1mg, Brexpipraxzole (OPC-34712) |
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| Cohort 3 | Experimental | 2mg, Brexpipraxzole (OPC-34712) |
|
| Cohort 4 | Experimental | 3 mg, Brexpipraxzole (OPC-34712) |
|
| Cohort 5 | Experimental | 4mg, Brexpipraxzole (OPC-34712) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole (OPC-34712) | Drug | Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Adverse Events (AEs) at 30 day Follow-Up | 30 day Follow-Up | |
| Change from Baseline to Day 17 in Vital Signs | Baseline to Day 17 | |
| Change from Baseline to Day 17 ECGs | Baseline to Day 17 | |
| Change from Baseline to Day 17 Hematology | Baseline to Day 17 | |
| Change from Baseline to Day 14 Physical examination | Baseline to Day 14 | |
| Change from Baseline to Day 17 Body weight | Baseline to Day 17 | |
| Change from Baseline to Day 17 Serum chemistry | Including Prolactin concentrations | Baseline to Day 17 |
| Change from Baseline to Day 17 Urinalysis | Baseline to Day 17 | |
| Maximal peak steady-state plasma concentration | At Day 14 | |
| Minimum trough steady-state plasma concentration | At Day 14 | |
| Time to maximum peak steady-state plasma concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in CGI-S score | Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase | |
| Mean change in CGI-I score | Day 7 and Day 14 | |
| Glycosylated haemoglobin [HbA1c] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72211 | United States | |||
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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|
| At Day 14 |
| Area under the concentration-time curve during the dosing interval at steady-state | At Day 14 |
| Terminal elimination half-life | At Day 14 |
| For Brex only, apparent cleanse and apparent volume of distribution | At Day 14 |
| Baseline to Day 17 |
| Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH] | Baseline to Day 17 |
| Change from Baseline to Day 17 Cortisol | Baseline to Day 17 |
| Change from Baseline to Day 17 Thyroid stimulating hormone [TSH] | Baseline to Day 17 |
| Change from Baseline to Day 17 Prothrombin time [PT] | Baseline to Day 17 |
| Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT] | Baseline to Day 17 |
| Change from Baseline to Day 17 International normalized ratio [INR] | Baseline to Day 17 |
| For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS) | Day-1 to Day 15 |
| For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS) | Day -1 to Day 15 |
| Culver City |
| California |
| 90230 |
| United States |
| Orange | California | 92858 | United States |
| Washington D.C. | District of Columbia | 20016 | United States |
| Atlanta | Georgia | 30331 | United States |
| Marlton | New Jersey | 08053 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44106 | United States |
| The Woodlands | Texas | 77381 | United States |
| Orem | Utah | 84058 | United States |
| 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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