Acute SchizophreniaPhase 3NCT06589817
A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia
A Phase 3 study testing Hydrochloride Carliprazine capsules and Aripiprazole tablets in people with Acute Schizophrenia, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
Trial summary
This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Schizophrenia
- What is being tested?
- Hydrochloride Carliprazine capsules and Aripiprazole tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 65 years, male and female;
- Subjects diagnosed with schizophrenia (according to the DSM-IV criteria);
- Subjects with a PANSS Total score between 70-120, with a score of at least 4 on two or more of the items of delusions, hallucinatory behavior, conceptual disorganization, or suspiciousness;
- Subjects with a CGI-S score ≥4;
- Subjects with a Body Mass Index (BMI) of between 18-40 kg/m2;
- Subjects and subject\'s legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the scheduled visits, report the adverse events and concomitant medication to investigators, and to be reliably rated on psychiatrically scales，and to provide written informed consent form by subjects and subject\'s legal guardian or legally acceptable representative.
Who cannot join
- Other mental illnesses that meet DSM-5 criteria, excluding schizophrenia, including but not limited to: major depressive disorder, bipolar disorder and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, bulimia nervosa/anorexia nervosa, neurodevelopmental disorders, schizoaffective disorder, and any other mental illness that may affect subject compliance;
- Subjects who have been hospitalized for \> 21 days for the current acute episode.
- Subjects with a history of substance abuse or dependence (excluding nicotine or caffeine) in the past 3 months, or those who test positive in the urine drug screening during the screening period (Subjects who test positive in the urine drug screening may be allowed to participate in the study at the researcher\'s discretion, or may participate if they cease using such substances prior to the trial). Use of narcotic analgesics for a maximum of 3 days is permitted during the trial for clinical medical needs;
- Subjects who have history of substance abuse or dependence within 3 months, but excluding caffeine and nicotine. Invesgtigators have the right to decide whether subjects who are positive in urine drug screening can be enrolled in the study, or those who have stopped drug use before screening can be enrolled. During the study, the use of up to 3 days of anesthetic analgesics is allowed for medical purposes.
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses.
- Subjects who have used long-acting antipsychotic drugs (such as risperidone long-acting injection, paliperidone long-acting injection , fluphenazine, aripiprazole long-acting injection , etc.) within 6 months before screening, or subjects who have received ≥15mg aripiprazole treatment within 14 days before screening.
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- Subjects who have taken \>200 mg/day clozapine for any reason, or ≤200 clozapine for the reason other than insomnia, agitation, or anxiety.
- Subjects with a history of psychosurgerytherapy, electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months before screening, or those who cannot stop physical therapy during the study.
- As judged by the investigator, subjects with risk of severe agitation, violent or destructive behaviors (harming self or othres, suicide).
- Subjects with risk for suicidal behavior during the study as determined by the investigator\'s clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
- Females who are pregnant or breastfeeding, or those are not willing or cannot practice contraceptive methods from the time of signing the ICF to 30 days after the last dose.
- Subjects with comorbidities that, in the view of the investigator, may interfere with the implementation of the trial or confound the trial results.
- Subjects with a history of ischemic heart disease or myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.
- Subjects with history of central nervous system diesease, including but not limited to stroke, tumor of central nervous system, Parkinson's disease, organic brain disorders, epilepsy or seizures, chronic infections, neurosyphilis, or previously suffered from traumatic brain injury.
- Subjects with history or presence of clinically significant organic disease, including but not limited to hepatic, renal, pulmonary, cardiovascular, endocrine, neurologic, hematologic, or autoimmunologic diseases.
- Subjects with history of ophthalmic disease, such as cataract, intraocular surgery (not including corneal refractive surgery), fundus laser therapy, open-angle or angle-closure glaucoma, retinal or corneal disease, severe ocular trauma or its complications, and acute bacterial or viral eye infections within 1 week before screening.
- Subjects with type I diabetes dellitus or uncontrolled type II diabetes mellitus. Subjects with type II diabetes may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:
- HbA1c \< 7.0%, and fasting glucose must be ≤ 7.0 mmol/L or non-fasting glucose must be ≤ 11.1 mmol/L at screening, AND
- If the non-fasting glucose is \>11.1mmol/L, subjects must be retested in a fasted state and the retest value must be ≤ 7.0 mmol/L, AND
- Subjects have maintained a stable regimen of oral anti-diabetic medication(s) for at least 28 days before screening or diabetes has been well-controlled by diet for at least 28 days before screening, AND
- Subjects have not had any hospitalizations within the 2 months before screening due to diabetes or complications related to diabetes, AND
- Subjects whose diabetes is not newly diagnosed during screening for the trial.
- Abnormal hepatic and renal function at screening, sucha as ALT, AST\>2×ULN or Cr \> 1.2 ×ULN.
- (18)Clinically significant abnormal finding on ECG at screening, such as QTcF≥450 ms (male) or ≥470 ms (female).
- (19)Positive test for HBsAg, HIV antibody, HCV antibody, and TP-Ab at screening.
- (20)If other significant abnormalities in laboratory findings and scales at screening, in the opinion of the investigator, subject is unsuitable for enrollment in the study.
- (21)Subjects with uncontrolled hypertension, symptomatic hypotension or orthostatic hypotension.
- (22)Subjects with history or presence of tardive dyskinesia or neuroleptic malignant syndrome.
- (23)Subjects with history of known allergy to carliprazine capsules, aripiprazole tablets, or their excipients, or highly sensitive person (defined as allergies to more than 2 substances); (24)Subject is unsuitable for enrollment in the study in the opinion of the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects
This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.
- Conditions
- Acute Schizophrenia
- Being tested
- Hydrochloride Carliprazine capsules, Aripiprazole tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrochloride Carliprazine capsulesDrug
Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.
Aripiprazole tabletsDrug
Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.
| Study group | Role | What they receive |
|---|---|---|
| Hydrochloride Carliprazine capsules + Aripiprazole tablet placebo | Experimental | Not described Receives: Drug: Hydrochloride Carliprazine capsules |
| Aripiprazole tablets + Hydrochloride Carliprazine capsules placebo | Active comparator | Not described Receives: Drug: Aripiprazole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS
Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.
Measured: week 6
Secondary outcomes (4)
PANSS
Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.
Measured: week 1.;week 2.;week 4
CGI-S
Change in Clinical Global Impression Severity Scale (CGI-S) score from baseline.
Measured: week 1.;week 2.;week 4.;week 6.
CGI-I
Change in Clinical Global Impression Improvement Scale (CGI-I) score from baseline.
Measured: week 1.;week 2.;week 4.;week 6.
PSP
Change in Personal and Social Performance Scale (PSP) score from baseline.
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 posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589817
- Sponsor's protocol ID
- KH734-60101
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Hydrochloride Carliprazine Capsules or Aripiprazole Tablets for the Treatment of Acute Schizophrenia Subjects
- ClinicalTrials.gov ID
- NCT06589817
- Acronym / sponsor ID
- KH734-60101
- Conditions
- Acute Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrochloride Carliprazine capsules + Aripiprazole tablet placebo | Experimental | Drug: Hydrochloride Carliprazine capsules |
| Aripiprazole tablets + Hydrochloride Carliprazine capsules placebo | Active comparator | Drug: Aripiprazole tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects between 18 and 65 years, male and female;
- Subjects diagnosed with schizophrenia (according to the DSM-IV criteria);
- Subjects with a PANSS Total score between 70-120, with a score of at least 4 on two or more of the items of delusions, hallucinatory behavior, conceptual disorganization, or suspiciousness;
- Subjects with a CGI-S score ≥4;
- Subjects with a Body Mass Index (BMI) of between 18-40 kg/m2;
Key exclusion criteria (29 listed)
- Other mental illnesses that meet DSM-5 criteria, excluding schizophrenia, including but not limited to: major depressive disorder, bipolar disorder and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, bulimia nervosa/anorexia nervosa, neurodevelopmental disorders, schizoaffective disorder, and any other mental illness that may affect subject compliance;
- Subjects who have been hospitalized for \> 21 days for the current acute episode.
- Subjects with a history of substance abuse or dependence (excluding nicotine or caffeine) in the past 3 months, or those who test positive in the urine drug screening during the screening period (Subjects who test positive in the urine drug screening may be allowed to participate in the study at the researcher\'s discretion, or may participate if they cease using such substances prior to the trial). Use of narcotic analgesics for a maximum of 3 days is permitted during the trial for clinical medical needs;
- Subjects who have history of substance abuse or dependence within 3 months, but excluding caffeine and nicotine. Invesgtigators have the right to decide whether subjects who are positive in urine drug screening can be enrolled in the study, or those who have stopped drug use before screening can be enrolled. During the study, the use of up to 3 days of anesthetic analgesics is allowed for medical purposes.
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses.
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 |
|---|---|---|
| Hydrochloride Carliprazine capsulesOral administration, once daily, with a total treatment duration of 6 weeks after successful screening. | Drug | Hydrochloride Carliprazine capsules + Aripiprazole tablet placebo |
| Aripiprazole tabletsOral administration, once daily, with a total treatment duration of 6 weeks after successful screening. | Drug | Aripiprazole tablets + Hydrochloride Carliprazine capsules placebo |
Primary outcome
PANSS
Time frame: week 6
Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.
4 secondary outcomes
PANSS
Time frame: week 1.;week 2.;week 4
CGI-S
Time frame: week 1.;week 2.;week 4.;week 6.
CGI-I
Time frame: week 1.;week 2.;week 4.;week 6.
PSP
Time frame: week 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrochloride Carliprazine capsules and Aripiprazole tablets in people with Acute Schizophrenia, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
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 29 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Zhao, PH.D (86-021-54252689, drminzhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS (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 19 Sep 2024.