SchizophreniaPhase 3NCT05168007
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
A Phase 3 study testing WID-RGC20(Cariprazine) 3mg/day and WID-RGC20(Cariprazine) 6mg/day in people with Schizophrenia, run by Whanin Pharmaceutical Company at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- WID-RGC20(Cariprazine) 3mg/day and WID-RGC20(Cariprazine) 6mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2021to 31 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension)
- Abnormal laboratory findings specified in protocol
- Not suitable for any other reason, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Schizophrenia
- Being tested
- WID-RGC20(Cariprazine) 3mg/day, WID-RGC20(Cariprazine) 6mg/day, Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/dayDrug
The placebo comparator is administered during the double-blind treatment period(6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine 3mg/day | Experimental | WID-RGC20(Cariprazine) 3 mg/day Receives: Drug: WID-RGC20(Cariprazine) 3mg/day |
| Cariprazine 6mg/day | Experimental | WID-RGC20(Cariprazine) 6 mg/day Receives: Drug: WID-RGC20(Cariprazine) 6mg/day |
| Placebo | Placebo comparator | Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day Receives: Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive And Negative Syndrome Scale(PANSS) total score
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
Measured: at Week 6
Secondary outcomes (1)
Clinical Global Impressions-Severity(CGI-S)
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
Measured: at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start19 Nov 2021
- Primary completion17 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whanin Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168007
- Sponsor's protocol ID
- WID-RGC20-P3
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05168007
- Acronym / sponsor ID
- WID-RGC20-P3
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Whanin Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 17 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 3mg/day | Experimental | Drug: WID-RGC20(Cariprazine) 3mg/dayWID-RGC20(Cariprazine) 3 mg/day |
| Cariprazine 6mg/day | Experimental | Drug: WID-RGC20(Cariprazine) 6mg/dayWID-RGC20(Cariprazine) 6 mg/day |
| Placebo | Placebo comparator | Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/dayPlacebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- Psychiatric Criteria
- Treatment-related Criteria
- Other
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WID-RGC20(Cariprazine) 3mg/dayThe 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). | Drug | Cariprazine 3mg/day |
| WID-RGC20(Cariprazine) 6mg/dayThe 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). | Drug | Cariprazine 6mg/day |
| Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/dayThe placebo comparator is administered during the double-blind treatment period(6 weeks). | Drug | Placebo |
Primary outcome
Positive And Negative Syndrome Scale(PANSS) total score
Time frame: at Week 6
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
1 secondary outcome
Clinical Global Impressions-Severity(CGI-S)
Time frame: at Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WID-RGC20(Cariprazine) 3mg/day and WID-RGC20(Cariprazine) 6mg/day in people with Schizophrenia, run by Whanin Pharmaceutical Company at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive And Negative Syndrome Scale(PANSS) total score (time frame: at Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.