A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olanzapine-samidorphan；, Olanzapine.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Overview
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
- Drug Olanzapine-samidorphan；
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks. - Drug Olanzapine
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
Primary outcome measures
- Percent change from baseline in body weight at Week 24. [Time frame: 24 weeks]
- Proportion of subjects with ≥10% weight gain at Week 24. [Time frame: 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06649214 · QLG1130-301