A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia

NCT06589817 | Not Yet Recruiting Phase 3

• 1 other identifier: KH734-60101
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief 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. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.

Conditions

Acute Schizophrenia

Outcome Measures

Primary Outcomes (1)

• PANSS

  Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.

  week 6

Secondary Outcomes (4)

• PANSS

  week 1.;week 2.;week 4

• CGI-S

  week 1.;week 2.;week 4.;week 6.

• CGI-I

  week 1.;week 2.;week 4.;week 6.

• PSP

  week 6.

Study Arms (2)

Hydrochloride Carliprazine capsules + Aripiprazole tablet placebo

EXPERIMENTAL

Drug: Hydrochloride Carliprazine capsules

Aripiprazole tablets + Hydrochloride Carliprazine capsules placebo

ACTIVE COMPARATOR

Drug: Aripiprazole tablets

Interventions

Hydrochloride Carliprazine capsules DRUG

Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.

Hydrochloride Carliprazine capsules + Aripiprazole tablet placebo

Aripiprazole tablets DRUG

Oral administration, once daily, with a total treatment duration of 6 weeks after successful screening.

Aripiprazole tablets + Hydrochloride Carliprazine capsules placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Min Zhao, PH.D

CONTACT

86-021-54252689; drminzhao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09