SCHIZOPHRENIA 1 (Disorder)
Conditions
Keywords
Schizophrenia, Long-term, open-label, HS-10380
Brief summary
The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.
Detailed description
The study will comprise 3 periods : a Screening Period, an Open-Label Treatment Period during which participants will be treated for 52 weeks and a 14-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 57 weeks.
Interventions
DRUGHS-10380
Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant is aged 18-65 years, inclusive, at screening. * Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening. * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria. * Willing and able to give informed consent/assent as per local requirements. * Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator.
Exclusion criteria
* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. * Judged by the investigator as having treatment-resistant schizophrenia. * Patients with risk of violent or destructive behavior, or suicidal risk. * History or presence of clinically significant disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. * Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria. * History of severe allergic reactions. * Female patients who are pregnant, in puerperium, or lactating at screening or baseline. * History of drug abuse within 1 year prior to screening. * History of alcohol abuse within 6 months prior to screening. * Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AE) | From first dose to end of study (Up to approximately 54 weeks ) | TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event. |
| Incidence and severity of serious adverse events (SAE) | From first dose to end of study (Up to approximately 52 weeks) | An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization ; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect. |
| Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation | From first dose to end of study (Up to approximately 54 weeks ) | TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | Open-label extension baseline, week 52 | The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions . PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. |
| Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score | Open-label extension baseline, week 52 | The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. |
Countries
China
Contacts
CONTACTTianmei Si
Outcome results
None listed