Schizophrenia
Conditions
Brief summary
The goal of this \[clinical trial\] is to \[evaluate the safety and efficacy of olanzapine-samidorphan tablets\] in \[adults with schizophrenia\]. The main question\[s\] it aims to answer are: * \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine. * \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.
Interventions
DRUGOlanzapine-samidorphan；
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.
DRUGOlanzapine
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subject is age 18 to 55 years, inclusive. * Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive. * Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia. * PANSS total score ≥ 70.
Exclusion criteria
* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with participation in the study. * Subject poses a current suicide risk in the opinion of the investigator. * Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder. * Subject has a history of diabetes. * Subject has used olanzapine, clozapine, chlorpromazine, or thioridazine at any time during the 6 months prior to screening or long-acting injectable antipsychotic medication in the last 6 months. * Subject has taken opioid agonists within the 14 days prior to screening and/or anticipates a need to take opioid medication during the study period, or has taken opioid antagonists within 60 days prior to screening. * Subject is taking any weight loss agents or hypoglycemic agents at screening. * Subject has had a surgical procedure for weight loss or is planning to have liposuction during the study. * Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight at Week 24. | 24 weeks |
| Proportion of subjects with ≥10% weight gain at Week 24. | 24 weeks |
Contacts
Primary ContactGang Wang, PhD
Outcome results
None listed