Clinical trial NCT05213143: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine
Official title: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: An open-label, single-arm and multi-center study for 16 weeks, to study the improvement of weight gain in patients with schizophrenia who switched from olanzapine to lurasidone.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. CGI-S ≤ 4 (at both Screening and Baseline)
  2. PANSS total score ≤ 70 at Screening and Baseline
  3. No exacerbation of schizophrenia has occurred for at least 8 weeks prior to screening

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.
* 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
* History of severe allergy or hypersensitivity;
* Angioedema occurred after previous administration of lurasidone;
* Patients who had previously participated in a clinical study 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;
* Any other conditions judged by the investigators that not suitable to participate in this study

Primary outcomes:
measure: Mean weight change
timeFrame: from baseline to week 16
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) scores
timeFrame: from baseline to week 16
measure: Change in the Clinical Global Impressions-Severity (CGI-S) scores
timeFrame: from baseline to week 16
measure: Change in 12-Item Short Form Survey (SF-12) scores
timeFrame: from baseline to week 16
measure: Change in waist circumference
timeFrame: from baseline to week 16
measure: Change in the serum prolactin (PRL)
timeFrame: from baseline to week 16
measure: Change in Calgary Depression Scale for Schizophrenia (CDSS) scores
timeFrame: from baseline to week 16
measure: Change in fasting lipids
timeFrame: from baseline to week 16
measure: Change in fasting plasma glucose
timeFrame: from baseline to week 16
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: from baseline to week 16
measure: Change in the Epworth Sleepiness Scale
timeFrame: from baseline to week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
Study officials:
References: