The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine

NCT05213143 | Terminated Phase 4 FDA Drug

• 1 other identifier: DSPC-LAT-002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, single-arm and multi-center study for 16 weeks

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean weight change

  Changes in body weight at the end of treatment compared to baseline

  from baseline to week 16

Secondary Outcomes (10)

• Change in Positive and Negative Syndrome Scale (PANSS) scores

  from baseline to week 16

• Change in the Clinical Global Impressions-Severity (CGI-S) scores

  from baseline to week 16

• Change in 12-Item Short Form Survey (SF-12) scores

  from baseline to week 16

• Change in waist circumference

  from baseline to week 16

• Change in the serum prolactin (PRL)

  from baseline to week 16

Study Arms (1)

Lurasidone

EXPERIMENTAL

Lurasidone was oral administrated with a meal or within 30 min after eating in the evening.

Drug: Lurasidone

Interventions

Lurasidone DRUG

Lurasidone was oral administrated with a meal or within 30 min after eating in the evening. The maintenance dose of olanzapine from Day 0 to Day 6, than tapered until discontinuation from Day 7 to Day 27. Lurasidone initiated with 40mg/d on Day 0, maintained until Day 13, with a flexible dose (40-80mg/d, qd) from Day 28 to Day 111.

Lurasidone

Eligibility Criteria

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

You may qualify if:

• Subject aged ≥ 18 to ≤ 65 years old
• Meet ICD-10 criteria for a primary diagnosis of schizophrenia， the duration must be at least one year
• Provide written informed consent (subject's legal guardian or impartial witness shall sign informed consent if the subject is unable to sign) and is willing and able to comply with the protocol in the opinion of the investigator.
• Considered to be an appropriate candidate for switching olanzapine due to safety or tolerability concerns
• Received Olanzapine monotherapy at a dose of 10 to 20mg/d for at least 8 weeks with a body mass index (BMI) ≥25kg/m2, the dose of olanzapine has been stable for at least 4 weeks prior to screening. Weight gain during current olanzapine therapy was verified in the subject history.
• Subject must meet the clinical stability as following criteria:
• CGI-S ≤ 4 (at both Screening and Baseline)
• PANSS total score ≤ 70 at Screening and Baseline
• No exacerbation of schizophrenia has occurred for at least 8 weeks prior to screening

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.
• 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
• Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications
• More than 10% weight loss 3 months prior to the screening period
• 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 need to take any potent CYP3A4 inhibitor (e.g., ketoconazole, ritonavir, clarithromycin, ritonavir, voriconazole, Mibefradil) or inducer (e.g. rifampicin, avasimibe, St. John's Wort, phenytoin, carbamazepine), drugs for external use in dermatological patients are excluded
• Subject has a history of treatment with clozapine for 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 in the following time prior to the enrolment
• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Anding 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 28, 2022
• Study Start: December 30, 2021
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)