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Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia | Clinical Trials | Clareo Health

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Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/Day and 6 mg/Day in Patients With Acute Psychotic Episode of Schizophrenia

NCT05168007•Whanin Pharmaceutical Company

View on ClinicalTrials.gov

Summary

This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.

Eligibility

Age

19 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients 19 ≤ age \< 65 years
•At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90)
•At least 1 psychotic episode within 1 year
•Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks
•80 ≤ PANSS total score ≤ 120
•Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms
•CGI-S score ≥ 4
•Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase

Exclusion Criteria

•1. Psychiatric Criteria
•* Medical history except schizophrenia specified in protocol
•* First-episode psychosis
•* Treatment-resistant schizophrenia within 2 years
•* Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS)
•* Have suicide risk
•2. Treatment-related Criteria
•* Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT
•* Concomitant treatment with 3 or more antipsychotics within 12 weeks
•* Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks
+8 more criteria

Locations (1)

Whan In Pharm.

Seoul, South Korea

Key Dates

Start Date

November 19, 2021

Primary Completion Date

July 17, 2023

Completion Date

July 31, 2023

Last Updated

December 22, 2021

Enrollment

342

ESTIMATED participants

Conditions

Schizophrenia

Interventions

WID-RGC20(Cariprazine) 3mg/day

DRUG

WID-RGC20(Cariprazine) 6mg/day

DRUG

Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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