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A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

NCT06649214 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2024-10-21

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-04-30
Completion
2026-05-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649214 on ClinicalTrials.gov