SchizophreniaPhase 3NCT03465787
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
A Phase 3 study testing Lurasidone HCL 160 mg and Quetiapine XR 600 mg in people with Schizophrenia, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone HCL 160 mg and Quetiapine XR 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Apr 2018to 26 Oct 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and aged between 19 and 75 years of age.
- Meets DSM-5 criteria for a primary diagnosis of schizophrenia.
- CGI-S ≥ 4 at screening and baseline.
- Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
- Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
- Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
Who cannot join
- The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)
- Subject has participated in a prior trial of lurasidone.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
- In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia
This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone HCL 160 mg, Quetiapine XR 600 mg
- Keywords
- Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HCL 160 mgDrug
Lurasidone HCL 2 80mg tablets, QD
Quetiapine XR 600 mgDrug
Quetiapine XR 2 300 mg tablets, QD
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone HCL 160 mg | Experimental | Lurasidone HCL 160 mg/day Receives: Drug: Lurasidone HCL 160 mg |
| Quetiapine XR 600 mg | Active comparator | Quetiapine XR 600 mg/day Receives: Drug: Quetiapine XR 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Total PANSS Score From Baseline at Week 6
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Measured: Week 6
Secondary outcomes (1)
Mean change in CGI-S score From Baseline at Week 6
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start9 Apr 2018
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Hee Yeon, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465787
- Sponsor's protocol ID
- BK-LuD-301
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2018
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03465787
- Acronym / sponsor ID
- BK-LuD-301
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 14 Mar 2018 (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 is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lurasidone HCL 160 mg | Experimental | Drug: Lurasidone HCL 160 mgLurasidone HCL 160 mg/day |
| Quetiapine XR 600 mg | Active comparator | Drug: Quetiapine XR 600 mgQuetiapine XR 600 mg/day |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent and aged between 19 and 75 years of age.
- Meets DSM-5 criteria for a primary diagnosis of schizophrenia.
- CGI-S ≥ 4 at screening and baseline.
- Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
- Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.
Key exclusion criteria (5 listed)
- The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia)
- Subject has participated in a prior trial of lurasidone.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
- In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
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 |
|---|---|---|
| Lurasidone HCL 160 mgLurasidone HCL 2 80mg tablets, QD | Drug | Lurasidone HCL 160 mg |
| Quetiapine XR 600 mgQuetiapine XR 2 300 mg tablets, QD | Drug | Quetiapine XR 600 mg |
Primary outcome
Mean change in Total PANSS Score From Baseline at Week 6
Time frame: Week 6
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
1 secondary outcome
Mean change in CGI-S score From Baseline at Week 6
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Jung Hee Yeon principal investigator
SMG-SNU Boramae Medical Center
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 Lurasidone HCL 160 mg and Quetiapine XR 600 mg in people with Schizophrenia, run by Bukwang Pharmaceutical 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in Total PANSS Score From Baseline at Week 6 (time frame: 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 8 Feb 2023.