EUCTR2017-001447-12-PL进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo- and Active controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 years old) 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
- 316
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
- •1. Written informed consent, assent, or both obtained from a legally acceptable representative (eg, guardian) or subject prior to the initiation of any protocol-required procedures. In addition, the subject must provide informed assent at screening and must be able to understand that he or she can withdraw from the trial at any time. All informed consent/assent procedures must be in accordance with the trial site’s IRB/IEC and local regulatory requirements.
- •2. Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent/assent. and at baseline (Day 1).
- •3. Subjects with a current primary diagnosis of schizophrenia, as defined by DSM-5 criteria and confirmed by the K-SADS-PL, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records). The initial diagnosis of schizophrenia must be made and documented initially by an adequately trained clinician (psychiatrist or local medical equivalent who is experienced in treating adolescents with schizophrenia), and the diagnosis should be confirmed afterwards by utilizing the K-SADS-PL performed by an adequately trained rater. (Subjects with a diagnosis of ADHD and treated with stimulants or other ADHD medications within 28 days are prohibited.)
- •4. Subjects who, in the investigator’s judgment, require treatment with antipsychotic medication(s).
- •5. Subjects with a PANSS Total Score = 80 at screening and at baseline (Day 1).
- •6. Ability, in the opinion of the principal investigator, of the subject and the subject’s legally acceptable representative (eg, guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications, to read and understand the written word in order to complete subject-reported outcomes measures, and to be reliably rated on assessment scales.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 480
- •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
- •Key exclusion criteria include the following:
- •Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
- •Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (eg, medication, illicit drug use).
- •Subjects who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of the baseline visit.
- •Subjects who are considered treatment resistant to antipsychotic medication, including aripiprazole or brexpiprazole, at an adequate dose and duration as confirmed by medical history, investigator judgment, or subject report. Subjects with a history of relapse due to lack of medication compliance or drug abuse can be considered based on investigator judgment.
- •Subjects who have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history (eg, suicide attempt in the past 1 year) or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of yes” on Questions 4 or 5 (current or over past 1 month) on the suicidal ideation section of the baseline screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions that would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator (eg, history of myocardial infarction or ischemic heart disease, arrhythmia, congestive heart failure, or cancer); subjects with a comorbid serious systemic illness that requires pharmacotherapy; subjects with any history of electroconvulsive therapy.
- •Subjects who test positive for drugs of abuse at screening. A positive test for amphetamines, barbiturates, opiates, benzodiazepines may not result in exclusion of the subjects if the investigator determines that the positive test is a result of prescription medicine(s). When a subject tests positive for cannabinoids (tetrahydrocannabinol) at screening, the investigator is required to evaluate the subject's ability to abstain from using this substance during the trial and to discuss his/her evaluation with the Medical Advisor prior to randomization.
研究者
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