Schizophrenia, schizoaffective disorder Schizophrenia
Conditions
Interventions
Period I (12 weeks: Switching period plus 4 weeks thereafter)
[Specified switching method]
After brexpiprazole is administered as an add-on to prior antipsychotics*, the dose of prior antipsychotics w
Sponsors
Nakagome Kazuyuki
Otsuka pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with schizophrenia or schizoaffective disorder according to DSM-5 (2) Patients who want to switch the medication to a new antipsychotic in expectation of better tolerability and efficacy than those of the current treatment with antipsychotics or reduction of dosing frequency or the number of concomitant medications (3) Patients capable of providing written informed consent in person. For patients who are minors, patients who are capable of providing written informed consent from both the patient and the legal representative of the patient. (4) Outpatients (5) Men and women aged between 18 and 65 years as of the day of informed consent (6) Patients whose chlorpromazine (CP) equivalent dose is 150 to 1000 mg/day during the 30 days prior to informed consent (7) Patients whose type of prior primary antipsychotics (*) has been unchanged for 30 days prior to informed consent * Definition of primary antipsychotics: Of all antipsychotics used, those of which chlorpromazine (CP) equivalent dose per day exceeds 50%. (8) Patients whose dose of prior primary antipsychotic meet the followings on the date of informed consent - Risperidone (RIS): 2-8 mg (equivalent to CP 200-800 mg/day) - Paliperidone (PPD): 3-12 mg (equivalent to CP 200-800 mg/day) - Olanzapine (OLZ): 5-20 mg (equivalent to CP 200-800 mg/day) (9) Patients whose chlorpromazine (CP) equivalent dose of all antipsychotics is 1000 mg/day or less on the day of informed consent
Exclusion criteria
Exclusion criteria: (1) Patients who are pregnant or plan to become pregnant (2) Patients who have used clozapine (3) Patients with neurological, hepatic (moderate to severe hepatic dysfunction [Child-Pugh classification B or C]), renal, metabolic, hematologic, immunological, cardiovascular, pulmonary, or digestive diseases of clinical concern. However, patients with symptoms that are mild or well controlled and considered not to interfere with safety and efficacy assessment may be enrolled. (4) Patients with HbA1c exceeding the international standard value of 6.5% (JDS value 6.1%) at screening (5) Patients with the following laboratory values at screening 1. Platelet count 75000/mm3 (/micro L) or less 2. Hemoglobin 9 g/dL or less 3. Absolute neutrophil count 1000/mm3 or less 4. AST >2-fold the upper limit of normal 5. ALT >2-fold the upper limit of normal 6. CPK >3-fold the upper limit of normal 7. Creatinine 2 mg/dL or more (6) Patients who have developed acute depressive symptoms within 30 days prior to informed consent and considered to require treatment with antidepressants (7) Patients who have undergone electroconvulsive therapy (ECT) within 60 days prior to informed consent (8) Patients who have received sustained-release antipsychotics within 90 days prior to informed consent (9) Patients who have been hospitalized due to psychiatric symptoms within 90 days prior to informed consent (10) Patients who have shown suicidal ideation within 180 days prior to informed consent and suicidal behavior in the recent 2 years, or patients who are considered to be at a high risk of suicide (11) Patients with substance abuse or dependence including alcohol and benzodiazepine within 180 days prior to informed consent (12) Patients contraindicated for brexpiprazole 1. Patients in coma 2. Patients under the strong influence of barbiturate and central nervous system depressants such as anesthesia 3. Patients on adrenaline 4. Patients with history of hypersensitivity to the components of brexpiprazole (13) Patients concomitantly taking CYP2D6 inhibitors (quinidine, paroxetine, etc.) or CYP3A4 inhibitors (itraconazole, clarithromycin, etc.) (14) Patients known to have deficient CYP2D6 activity (15) Patients considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study (16) Patients who have previously participated in studies of OPC-34712 (17)Patients who have previously received brexpiprazole (Rexulti tablet)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment continuation rate 1* at Week 12 of treatment with brexpiprazole 1*: Treatment continuation refers to cases where the medication is switched to brexpiprazole in compliance with the specified method and the duration of treatment with brexpiprazole is no less than 85 days. Other cases will be deemed to be treatment non-continuation. In addition, if any of the limited concomitant medications is used, the case will be deemed to be treatment non-continuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in SLOF (2) Change from baseline in SWNS (3) Treatment continuation rate 2** at Week 12 of treatment with brexpiprazole 2**: Treatment continuation refers to cases where the medication is switched to brexpiprazole in compliance with the specified method and the duration of treatment with brexpiprazole is more than 85 days. Other cases will be deemed to be treatment non-continuation. | — |
Contacts
Public ContactHideki Oi
National Center of Neurology and Psychiatry
Outcome results
None listed