CTRI/2023/05/052793已完成4 期
A Prospective, Multi-centre, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Cariprazine Capsules in Adult Patients with Schizophrenia and Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 7
- 主要终点
- Proportion of participants with treatment-emergent adverse events (TEAEs) [Time frame: Throughout the study period]
研究概览
简要总结
This will be a prospective, multicentre, single-arm, Phase IV, open-label study. The study will be conducted at approximately 15 to 20 centres in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.
The patient will be screened only after obtaining written informed consent and will be undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). Screening number will be allotted to every screened patient. At screening visit, the Investigator or his/her designee will provide prospective patient with a detailed description of the study objectives, study participation requirements, as well as potential health risks and benefits associated with study participation. After obtaining written informed consent, study-specific screening [including inclusion and exclusion criteria, medical and medication history, demography, vitals, physical and laboratory examination, 12-Lead Electrocardiogram (ECG), PANSS score, YMRS score, CGI-S score, CGI-BP score and MADRS score] will be performed. Evaluation of concomitant medications and adverse/ serious adverse events will be done.
After confirming the eligibility, patients will be enrolled by allotting the enrollment number. The enrolled patients will be given study drugs Cariprazine Capsules 1.5 mg/3 mg/4.5 mg/ 6 mg once daily as mentioned in the section 10.1 Treatments Administered for the Investigational product dosage. Treatment duration will be 6 weeks for schizophrenia patient, and 3 weeks for Bipolar I disorder patient.
Efficacy endpoints assessment for a particular patient will be done by the same assessor (psychiatrist) for all the study visits.
Patients will be provided with diary to record details about study drug administration and adverse events. Patients will be required to bring completed diary of previous visit at upcoming visit to facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender aged between 18 to 65 years both inclusive who agree to provide written informed consent Patients eligible to continue as outpatients based on the opinion of the Investigator; and must have a caregiver to ensure treatment compliance Body mass index between 18 and 40 kg per m2eter square both inclusive Subjects willing to discontinue all prohibited medications to meet protocol required washouts prior to enrolment and during the treatment period and patients on psychotropic medications other than the allowed medication will undergo a washout period Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication such contraception may include hormonal birth control e g combined estrogen and progestogen containing oral intravaginal or transdermal or progesterone only oral injectable or implantable hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence Note Women with childbearing potential are defined as those who are not 1 surgically sterile bilateral oophorectomy hysterectomy or bilateral tubal ligation or 2 post menopausal Post menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural spontaneous amenorrhea and be greater than 45 years of age Male patients must have had a successful vasectomy confirmed azoospermia or they and their female partners must meet the criteria above i e not of childbearing potential or practicing highly effective contraception throughout the study period No sperm donation is allowed during the study period Patients with diagnosis of schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders criteria at least 1 year prior to enrolment Patients with a diagnosis of bipolar I disorder manic or mixed type with or without psychotic symptoms based on the DSM V Diagnosis should be confirmed by the Mini International Neuropsychiatric Interview and a history of at least one previous manic episode with or without mixed features with manic symptoms Patients with Montgomery–Asberg Depression Rating Scale Total score <18 at the time of screening and enrolment.
排除标准
- •Patients with treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose range (specifically for Schizophrenia) Patients with treatment resistant Bipolar I disorder (treatment with clozapine in a dose of > 50 mg/day in the past 2 years), or patients considered unresponsive to clozapine or who are only responsive to clozapine (specifically for Bipolar I disorder) Four or more episodes of a mood disturbance depression mania hypomania or mixed state) within the 12 months before screening (specifically for Bipolar I disorder) Patients who are Rapid cyclers (with more than 6 episodes in the previous year (specifically for Bipolar I disorder) Patients with a history of DSM-5 diagnosis of bipolar I disorder (for schizophrenia), and schizophrenia (for Bipolar I disorder), schizoaffective disorder, major depressive disorder, Bipolar II disorder, attention-deficit/hyperactivity disorder, delirium, dementia, amnestic, or other cognitive disorders; known or suspected borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder within 3 months prior to screening Patients who require hospitalization as judged by the investigator at time of enrolment Patients on antipsychotic medication(s) that require washout period (as mentioned in the Section 10.6) that is not feasible for the patient as per the investigator’s judgment Patients on Cytochrome (CYP) 3A4 inducer(s) or CYP2D6 inhibitors Patients with treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose range (specifically for Schizophrenia) Patients with treatment resistant Bipolar I disorder (treatment with clozapine in a dose of > 50 mg/day in the past 2 years), or patients considered unresponsive to clozapine or who are only responsive to clozapine (specifically for Bipolar I disorder) Four or more episodes of a mood disturbance depression mania hypomania or mixed state) within the 12 months before screening (specifically for Bipolar I disorder) Patients who are Rapid cyclers (with more than 6 episodes in the previous year (specifically for Bipolar I disorder) Patients with a history of DSM-5 diagnosis of bipolar I disorder (for schizophrenia), and schizophrenia (for Bipolar I disorder), schizoaffective disorder, major depressive disorder, Bipolar II disorder, attention-deficit/hyperactivity disorder, delirium, dementia, amnestic, or other cognitive disorders; known or suspected borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder within 3 months prior to screening Patients who require hospitalization as judged by the investigator at time of enrolment Patients on antipsychotic medication(s) that require washout period (as mentioned in the Section 10.6) that is not feasible for the patient as per the investigator’s judgment Patients on Cytochrome (CYP) 3A4 inducer(s) or CYP2D6 inhibitors Patients with hypothyroidism or hyperthyroidism unless condition has been stabilized with medications for at least within the past 3 months as per Investigator discretion or an abnormal result for free T4 at screening Patients with severe hepatic impairment Child Pugh score between 10 and 15 and severe renal impairment Electroconvulsive therapy in the 3 months before enrolment or previous lack of response to electroconvulsive therapy Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before enrolment At imminent risk of injuring self or others or causing significant damage to property as judged by the Investigator Suicide risk as determined by the following criteria a suicide attempt within the past 2 years b significant risk as judged by the Investigator based on the psychiatric interview or information collected in the Columbia Suicide Severity Rating Scale Patients with documented disease of the central nervous system that can interfere with the trial assessments including but not limited to stroke tumor Parkinsons organic brain disease seizure disorder except for febrile convulsions during infancy chronic infection or neurosyphilis or patients who have suffered a traumatic brain injury resulting in significant impairment Patients with clinically significant cardiovascular, hepatic, renal, metabolic including uncontrolled type II diabetes mellitus HbA1C more than 7% hematological immunological pulmonary or gastrointestinal disorders as judged by the investigator Patients with concurrent medical conditions that in the judgment of the Investigator might interfere with the conduct of the trial confounded the interpretation of the trial results or endangered the patients well being Patients with known history of cataracts or retinal detachment Patients with gastric bypass or any condition that would be expected to affect drug absorption Patients with history of meeting DSM-5 criteria for alcohol or substance abuse or dependence within the 6 months before enrolment Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before enrolment or during the study Pregnant breastfeeding or planning to become pregnant or breastfeed during the study Employee or immediate relative of an employee of the Sponsor any of its affiliates or partners or the study center.
结局指标
主要结局
Proportion of participants with treatment-emergent adverse events (TEAEs) [Time frame: Throughout the study period]
时间窗: Time frame: Throughout the study period
次要结局
- 1. Change in PANSS total score from baseline(2. Change in PANSS positive subscale score from baseline)
- 1.Change in YMRS total score from baseline (Time frame: Days 7, 14 & 21)(2. Change in Clinical Global Impression - Bipolar Version (CGI-BP) score from baseline (Time frame: Days 7, 14 & 21))
研究者
研究点 (7)
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