Schizophrenia Schizophrenia
Conditions
Interventions
6-week drug treatment period (Week0 to week6)
(1) lurasidone group
According to the patient allocation, 40 mg of lurasidone hydrochloride is administered orally once daily after meal. The dosage may b
Lurasidone, Paliperidone
Sponsors
Nakagome Kazuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who meet the DSM-5 criteria for schizophrenia 2) Patients who have the capacity to give consent and who are able to give written consent from themselves. 3) Outpatients 4) Male and female patients aged 18-60 years on the date of informed consent 5) Patients who wish to switch to an antipsychotic medication and to whom their physician agrees 6) Patients who are not at risk of self-injury or other injury during the past 6 months from the date of informed consent 7) Patients without acute illness requiring treatment 8) For patients with chronic disease (E.G., hypertension), treatment was continued for 1 month prior to participation and the patient's condition remained stable 9) Patients who can participate in 2 weekly cognitive rehabilitation sessions (Each session lasts approximately 60 to 75 minutes) 10) Patients who can undergo neuropsychological evaluation (BAC App) 11) Patients with an antipsychotic chlorpromazine (CP) equivalent of 1,000 mg/day or less in the past 30 days from the date of informed consent. 12) Patients whose primary antipsychotic type has not changed in the last 30 days from the date of informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with pre-morbid IQ less than 70 on the JART-25 test 2) Patients with impaired hearing or vision 3) Patients whose native language is not Japanese 4) Patients currently being treated with lurasidone, paliperidone, or clozapine 5) Patients taking three or more antipsychotic drugs 6) Patients taking antiparkinsonism drugs in excess of the 3 mg/day equivalent of biperiden hydrochloride 7) Patients with a history of resistance to treatment as evidenced by the fact that over the past 12 months from the date of informed consent, treatment with at least 2 appropriate doses of antipsychotics (dose indicated in the package insert) for at least 6 weeks did not improve the outcome. 8)Patients under treatment with psychotropic drugs known to affect cognitive function such as methamphetamine etc. 9)Patients who have received an antipsychotic sustained-release injection in the past 6 weeks from the date consent was obtained. 10)Patients with a history of electroconvulsive therapy (ECT) during the past 6 months from the date of informed consent, or patients with a history of potential need for ECT during the study. 11) Patients who are likely to have attempted suicide during this study. 12) Patients with a history of intracranial disease or CNS disease (E.G., stroke, traumatic brain injury, epilepsy, parkinsons disease,etc.). 13) Patients with clinically serious physical disorders 14) Patients with a history of alcohol, drug abuse, or dependence within the past 6 months from the date of consent. 15) Pregnant women or women who wish to become pregnant. 16) Women who are breastfeeding. 17) Patients who have undergone cognitive rehabilitation within 6 months prior to screening test 18) Patients with contraindications to latuda tablets a) Comatose patient b) Patients under the strong influence of central nervous system depressants such as barbiturates c) Patients requiring treatment with a potent CYP3A4 inhibitor (azole antifungals (itraconazole, voriconazole, miconazole (oral agent, oral cavity agent, parenteral ingection), fluconazole, fosfluconazole, posaconazole), HIV protease inhibitors (ritonavir, lopinavir/ritonavir, nelfinavir, darunavir, atazanavir, fosamprenavir), preparations containing cobicistat, clarithromycin, etc.) or a potent CYP3A4 inducer (rifampin, phenytoin, etc.). d) Patients receiving epinephrine (unless epinephrine is used for emergency treatment of anaphylaxis) e) Patients with a history of hypersensitivity to ingredients of latuda tablets 19) Patients with contraindications to paliperidone products a) comatose patient b) Patients under the strong influence of central nervous system depressants such as barbiturates c) Patients receiving epinephrine (unless epinephrine is used for emergency treatment of anaphylaxis) d) Patients with a history of hypersensitivity to ingredients of paliperidone and risperidone. e) Patients with moderate to severe renal impairment (CrCl < 50 mL/min) 20) Patients judged to be inappropriate as research subjects by the investigator and the sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of change in the BAC App composite T-score from baseline at the end of the 24 weeks NEAR treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of change in PANSS The amount of change in BNSS The amount of change in MADRS The amount of change in BAC App sub-item T-score The amount of change in UPSA-B The amount of change in SLOF The amount of change in SQLS The amount of change in EuroQol-5D-5L (EQ 5D-5L) The amount of change in WPAI The amount of change in DPB Adverse event DIEPSS Vital signs Height, weight Laboratory values (hematology and clinical chemistry) | — |
Contacts
Public ContactHideki Oi
National Center of Neurology and Psychiatry
Outcome results
None listed