EUCTR2018-004590-27-BG进行中（未招募）1 期
2-year, Multicentre, Open-label, Flexible-dose Study to Evaluate the Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures
- •- Male or female patients must be 13 to <18 years of age at the time of obtaining the patient’s informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.
- •- Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician.
- •- PANSS total score = 60 at Screening and Baseline.
- •- Score of = 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline.
- •-CGI-S score = 4 at Screening and Baseline.
- •- Patients must agree to sexual abstinence or to use a highly effective contraceptive method (see Section 16.1) during the study and for 10 weeks after the last dose of the IMP. Male patients must agree to refrain from donating sperm during this period. Women using systematically acting hormonal contraceptives should add a second barrier method (e.g. male condom, diaphragm or cervical cap).
- •- Patient must have a caregiver who is willing and able to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of study intervention, and accompany the patient to all study visits. Written consent from the caregiver must be obtained.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- •- Patient has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
- •- Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
- •- 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 (according to the drug’s package insert).
- •- Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to
- •Baseline (Visit 2).
- •- Patient requires concomitant treatment with any prohibited medication, supplement or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component with the exception of permitted treatment
- •- Positive UDS for substances of abuse at Screening. Exception: patients with a positive UDS at Screening for opiates, cannabinoids, amphetamines, or benzodiazepines may be allowed in the study provided all 3 of the following apply:
- •o The drug was used for a legitimate medical purpose with the exception of poppy seed consumption;
- •o The drug can be discontinued prior to further participation in the study (except for benzodiazepines which may be continued if the dose [lorazepam up to 2 mg/d or its benzodiazepine equivalent, with the exception of phenazepam] has been stable for at least 1 month prior to Baseline (Visit 2) or if used as a rescue medication, consistent with section 10.7.2. and 10.7.3 in the protocol.)
- •o A repeat UDS is negative for these substances prior to Baseline (Visit 2), except benzodiazepine use as described above.
- •- Patients who meet any of the following ophthalmological criteria:
- •o A history of cataracts
- •o Any clinically significant ocular trauma or complications of ocular trauma, or history of retinal detachment, intraocular surgery or laser treatment
- •o History of ocular disease (open- or narrow-angle glaucoma, retinopathies, corneal diseases)
- •o History of amiodarone or systemic corticosteroid use for = 3 consecutive months in the past year
- •- For female patients, positive pregnancy test at Screening or nursing or planning a pregnancy at any time during participation in the study.
- •- History of suicide attempt within 6 months of Screening in the judgement of the Investigator.
- •- Current suicidal or homicidal ideation judged clinically significant by the Investigator.
- •Please refer to section 9.2 of the protocol for more information.
研究者
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