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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
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