The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia

NCT05011669 | Completed Phase 4

• 1 other identifier: DSPCLAT-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Percentage of discontinuation due to adverse events

  during the 6 weeks of treatment

Study Arms (2)

Latuda® 40mg/d

EXPERIMENTAL

Drug: Lurasidone

Latuda® 80mg/d

EXPERIMENTAL

Drug: Lurasidone

Interventions

Lurasidone DRUG

Oral administration with a meal or within 30 min after eating in the evening. The dosage could be adjusted from Day 8.

Latuda® 40mg/d; Latuda® 80mg/d

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 18, 2021
• Study Start: August 16, 2021
• Primary Completion: April 16, 2023
• Study Completion: June 16, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (1)