Clinical trial NCT05011669: The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia
Official title: The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Lurasidone initiated with 40mg and 80mg in treatment with acute phase patients with schizophrenia


Eligibility criteria: Inclusion Criteria:

* Subjects meet ICD10 criteria for a primary diagnosis of schizophrenia;
* Subjects have a score ≥ 4 on the CGI-S at Screening and Baseline;
* Subjects have a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, with a score 4 (moderate) or higher in 2 or more items on the following PANSS items: delusions, conceptual disorganization, hallucinations, unusual thought content and suspiciousness;
* Subjects with acute (including recurrence /relapse and first episode) phase patients with schizophrenia;
* Ability to understand the contents of interview and provide written informed consent (If subject is unable to sign, subject's legal guardian or impartial witness shall sign the informed consent).

Exclusion Criteria:

* Subjects with severe or unstable physical diseases (including but not limited to severe or unstable cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases) determined by the investigators;
* Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications;
* Based on the judgement of investigators, subject has a history of refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of baseline;
* Subjects has used long-term antipsychotic drugs, e.g. Haloperidol decanoate injection, Fluphenazine decanoate injection, Risperidone microspheres injection, Paliperidone palmitate injection, Paliperidone palmitate injection (3M), in the following time prior to the enrolment;
* Subjects is at risk of suicide or self-mutilation behaviours or the act of endangering others, or other corresponding characteristic behaviour, or a history of suicide;
* Female subjects were pregnant (positive pregnancy test at screening) or breast-feeding or planning pregnancy for the duration of the study, or the partners of male subjects were planning pregnancy for the duration of the study;
* Need to use of disallowed concomitant therapy which is specified in the protocol;
* History of severe allergy or hypersensitivity;
* Currently has severe liver function impairment, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal value;
* Creatinine clearance rate \< 50mL/min Creatinine clearance rate\*100%= Male: (140 - Age) x Weight(kg)/Serum creatinine (mg/dL) x 72 Female: 0.85\*(140 - Age) x Weight(kg)/Serum creatinine (mg/dL) x 72
* A history of malignant tumors (including benign pituitary tumors);
* Any chronic organic disease of the central nervous system (excluding schizophrenia), such as CNS related tumors and inflammation, active seizures, vascular disease, Parkinson's disease, Alzheimer's disease, or other forms of dementia, myasthenia gravis, and other degenerative diseases. A history of mental retardation or persistent neurological symptoms caused by severe head injury;
* Subjects received electroconvulsive therapy (ECT) within 90 days prior to screening, or were expected to require ECT during the study;
* A history of neuroleptic malignant syndrome;
* Severe tardive dyskinesia, severe dystonia, or any other severe dyskinesia;
* Angioedema occurred after previous administration of lurasidone;
* The subject is participating in or has participated in other clinical trials, including the use of commercially available drugs or medical devices, within 30 days prior to the signing of the informed consent;
* Patients who had previously participated in a clinical study of lurasidone;
* Any other conditions judged by the investigators that not suitable to participate in this study.

Primary outcomes:
measure: Percentage of discontinuation due to adverse events
timeFrame: during the 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
References: