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NOT YET RECRUITING
NCT07703956
PHASE2

Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia Adults

Sponsor: Vigonvita Life Sciences

View on ClinicalTrials.gov

Summary

This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.

Official title: A Phase 2,Multicenter, Randomized, Double-blind, Placebo and Active Comparator Parallel-controlled Study to Evaluate the Safety and Efficacy of VV119 in Adults With Acute Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-07-31

Completion Date

2027-12-31

Last Updated

2026-07-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

VV119 2mg

VV119 capsules 1 capsule (2mg/capsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets

DRUG

VV119 4mg

VV119 capsules 2 capsules (2mg/capsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets

DRUG

VV119 6mg

VV119 capsule 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets

DRUG

Aripiprazole tablet

VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet 2 tablets

DRUG

Placebo

VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets

Locations (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China