CTRI/2025/11/097252尚未招募3 期
A Multicentric, Prospective, Parallel Group, Randomized, Double Blind, Double Dummy, Active Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Brexpiprazole Tablets in Comparison with Aripiprazole Tablets in Adult Patients for the Treatment of Acute Schizophrenia.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Mean change in positive and negative syndrome scale (PANSS) total score from baseline to end of the treatment visit i.e., week 6.
研究概览
简要总结
Patients with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria, newly diagnosed acute schizophrenia or acute relapse of schizophrenia episodes prior to screening will be screened (visit 1) within 2 weeks prior to their randomization. The eligible patients will then be randomized to either of the 2 study groups as per their randomization number on randomization visit (visit 2, day 1). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 1 (visit 3), week 2 (visit 4), week 3 (visit 5), week 4 (visit 6), week 6 (visit 7 - end of the treatment visit) and week 7 (visit 8 - end of the study. This will be a parallel group study and all the enrolled patients will be instructed to take the study drugs as per the prescribed regimen for a treatment period of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged between 18 to 65 years (both inclusive).
- •Patients with documented diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
- •Patients with newly diagnosed acute schizophrenia or acute relapse of schizophrenia episodes.
- •Patients with a Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70 at screening visit.
- •Patients with a Clinical Global Impressions – Severity (CGI-S) score greater than or equal to 4 at screening visit.
- •Patients with relapse, who had received previous outpatient antipsychotic treatment at an adequate dose for the treatment of schizophrenia for an adequate duration and who showed a previous good response to such antipsychotic treatment (other than Clozapine) in the 12 months prior to screening, according to the investigator’s opinion.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of the study visit.
- •Patient with ability to understand and provide written, signed and dated informed consent form which must have been obtained prior to screening.
- •Patients are willing and able to comply with all the protocol requirements.
排除标准
- •Patients with intolerance, contraindication or potential allergy or hypersensitivity to study drug or drugs of similar chemical class.
- •Patients with a medical history of resistant or refractory to antipsychotic treatment.
- •Patients with a medical history of failure to respond to Clozapine or respond to Clozapine treatment only.
- •Patients who are already hospitalized or who required hospitalization for the treatment of a current episode of schizophrenia as per the investigator’s opinion.
- •Patients with a history of electroconvulsive therapy (ECT) for the treatment of schizophrenia episodes.
- •Patients diagnosed with dementia-related psychosis.
- •Patients with a diagnosis of mental retardation or other cognitive disorder, any other Axis I psychiatric diagnosis.
- •Patients who are currently receiving antipsychotic drug therapy.
- •Patients deemed by the investigator to be at imminent risk of suicide or self-harm, harm to others or property damage.
- •Patients with a history of clinically significant suicidal or homicidal behavior or attempts within the past 6 months.
- •Patients who received Clozapine for any reason other than schizophrenia within the last 4 months prior to randomization.
- •Patients who received treatment with mood stabilizers or antidepressants within 1 week, Fluoxetine Hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor within 3 weeks prior to screening.
- •Patients with a medical history of Neuroleptic Malignant Syndrome (NMS).
- •Patients with documented evidence of severe tardive dyskinesia, severe dystonia or any other severe movement disorder.
- •Patients with a medical history of pituitary adenoma or hyperprolactinemia (prolactin concentration greater than 100 ng by mL at screening).
- •Patients who have received or are currently receiving depot neuroleptics.
- •Patients with clinically significant impaired hepatic function (i.e., AST, ALT and ALP more than 2.5X the ULN and or Total bilirubin more than 1.5X the ULN) at screening visit.
- •Patients with serum creatinine levels greater than or equal to 2 mg by dL at screening visit.
- •Patients who require Insulin therapy for the management of diabetes.
- •Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than or equal to 7%.
- •Patients with uncontrolled thyroid disease and or abnormal free thyroxine (FT4) examination results at screening, unless it has been confirmed by the investigator that the condition has been stabilized by medication greater than 90 days before screening.
- •Patients with known cases of infection with hepatitis B, hepatitis C or HIV.
- •Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •Patients with significant cardiovascular history defined as: myocardial infarction, congestive heart failure (whether controlled or uncontrolled), unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
- •Patients with clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal and/or urological disorder.
- •Patients who require treatment with strong CYP3A4 inhibitors (e.g., Ketoconazole) or strong CYP3A4 inducers (e.g., Rifampin) during the study.
- •Patients with any abnormality on 12-lead ECG [QTc greater than or equal to 450 msec (for males) or greater than or equal to 470 msec (for females)] at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Mean change in positive and negative syndrome scale (PANSS) total score from baseline to end of the treatment visit i.e., week 6.
时间窗: Visit 2 - Baseline or Randomization visit (Day 1) and | Visit 7 - End of the treatment visit / Week 6 (Day 43±2).
次要结局
- Mean change in positive and negative syndrome scale (PANSS) total score from baseline to week 1, week 2, week 3 and week 4.(Visit 2 - Baseline or Randomization visit (Day 1),)
- Proportion of responders in positive and negative syndrome scale (PANSS) at week 1, week 2, week 3, week 4 and week 6.(Visit 3 - Follow up visit / Week 1 (Day 8±1),)
- Change in clinical global impression - severity (CGI-S) from baseline to week 1, week 2, week 3, week 4 and week 6.(Visit 3 - Follow up visit / Week 1 (Day 8±1),)
- Change in clinical global impression - improvement (CGI-I) from baseline to week 1, week 2, week 3, week 4 and week 6.(Visit 3 - Follow up visit / Week 1 (Day 8±1),)
- Mean change in positive and negative syndrome scale (PANSS) positive subscale score from baseline to week 1, week 2, week 3, week 4 and week 6.(Visit 3 - Follow up visit / Week 1 (Day 8±1),)
- Mean change in positive and negative syndrome scale (PANSS) negative subscale score from baseline to week 1, week 2, week 3, week 4 and week 6.(Visit 3 - Follow up visit / Week 1 (Day 8±1),)
- Adverse events and serious adverse events reported during the study.(Throughout the study.)
- Changes in clinical laboratory parameters from screening to end of the treatment visit (Week 6).(Visit 1 - Screening visit (up to -2 weeks) and)
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.
研究点 (9)
Loading locations...
相似试验
尚未招募
不适用
Study to Understand the effects of Glimepiride, Dapagliflozin and Metformin Combination Tablets in Indian Diabetic PatientsCTRI/2026/01/101076Torrent Pharmaceuticals Ltd.25,000
已完成
3 期
Efficacy and Safety of Fixed Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate in Comparison to Leuprolide in Heavy Menstrual Bleeding Associated With Uterine FibroidsCTRI/2025/01/078944AKUMS DRUGS PHARMACEUTICALS LTD338
招募中
3 期
Effectiveness and safety study of Inj. Pembrolizumab in patients with Lung cancerCTRI/2025/07/090716Hetero Biopharma Limited228
尚未招募
2 期
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung CancerNCT07318883Shanghai Henlius Biotech720
招募中
Phase 3 4
To Study the Effect and Safety of Raktamrut Vati Along with Standard Treatment in People with Hemophilia.CTRI/2025/07/090910Dr. Shubham Ramnarayan Dhoot100