NCT05168007

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
342

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

November 26, 2021

Last Update Submit

December 8, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive And Negative Syndrome Scale(PANSS) total score

    Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6

    at Week 6

Secondary Outcomes (1)

  • Clinical Global Impressions-Severity(CGI-S)

    at Week 6

Other Outcomes (10)

  • Positive And Negative Syndrome Scale(PANSS) total score

    up to 5 weeks

  • Clinical Global Impressions-Severity(CGI-S)

    up to 5 weeks

  • Clinical Global Impressions-Improvement(CGI-I)

    up to 6 weeks

  • +7 more other outcomes

Study Arms (3)

Cariprazine 3mg/day

EXPERIMENTAL

WID-RGC20(Cariprazine) 3 mg/day

Drug: WID-RGC20(Cariprazine) 3mg/day

Cariprazine 6mg/day

EXPERIMENTAL

WID-RGC20(Cariprazine) 6 mg/day

Drug: WID-RGC20(Cariprazine) 6mg/day

Placebo

PLACEBO COMPARATOR

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

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

Interventions

WID-RGC20(Cariprazine) 3mg/dayDRUG

The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(3mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).

Cariprazine 3mg/day
WID-RGC20(Cariprazine) 6mg/dayDRUG

The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(6mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).

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

The placebo comparator is administered during the double-blind treatment period(6 weeks).

Placebo

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • ≤ 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

You may not qualify if:

  • 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
  • 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
  • Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors
  • Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year
  • Required prohibited concomitant medication during the study period
  • Prior participation in any clinical trials of Cariprazine
  • Other
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whan In Pharm.

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 22, 2021

Study Start

November 19, 2021

Primary Completion

July 17, 2023

Study Completion

July 31, 2023

Last Updated

December 22, 2021

Record last verified: 2021-12

Locations

KR(1)