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A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia

NCT07521683 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-13

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to preliminarily evaluate the efficacy and safety of NS-136 in patients with schizophrenia. The study consists of a screening period, baseline period, treatment period, and follow-up period, with the screening period lasting up to 21 days.

Eligible subjects will be randomized in a 1:1:1 ratio to the 80 mg (QD) group, 120 mg (QD) group, or placebo group. The study drug treatment will last for 5 weeks, followed by a 2-week safety follow-up after completion of the study.

Conditions

  • Schizophrenia(Acute)

Interventions

DRUG

NS-136

NS136 80mg and 120mg

Sponsors & Collaborators

  • NeuShen Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT07521683 on ClinicalTrials.gov