EUCTR2017-002222-20-PL进行中（未招募）1 期
A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 322
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. Male or female subjects, ages 18 to 65 years, inclusive, at the time of informed consent.
- •2. Subjects who are able to complete the consent process as required by IRB or IEC prior to the initiation of any protocol-required procedures.
- •3. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited medication; and to read and understand written word in order to be reliably rated on assessment scales.
- •4. Subjects with a DSM-5 diagnosis of bipolar I disorder displaying an acute manic episode with or without mixed features requiring hospitalization. Diagnosis confirmed by the MINI and a history of at least one previous manic episode with or without mixed features with manic symptoms of sufficient severity to require one of the following interventions: hospitalization or treatment with a mood stabilizer, or treatment with an antipsychotic agent. Require” is defined as an intervention that occurred rather than one that was recommended.
- •5. YMRS score of = 24 at screening and baseline.
- •6. Subjects who, in the investigator’s judgment, require treatment with an atypical antipsychotic medication for their bipolar I disorder.
- •7. Subjects willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 329
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Sexually active male or WOCBP (women of childbearing potential) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP.
- •2. Females who are breastfeeding and/or who have a positive pregnancy test result prior to receiving trial medication.
- •3.Subjects considered unresponsive to clozapine or who are only responsive to cloazapine.
- •4. Subjects with a history of DSM-5 diagnosis other than bipolar I disorder, including schizophrenia, schizoaffective disorder, major depressive disorder, attention-deficit/hyperactivity disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. All other current diagnoses must be discussed with the medical monitor.
- •5. Subjects whose current manic episode has lasted for more than 4 weeks overall, or who have required hospitalization > 21 days for the current acute episode at the time of the screening visit, excluding hospitalization for psychosocial reasons.
- •6. Subject with manic symptoms better accounted for by another general medical condition or direct physiological effect of substance (eg. medication)
- •7. Subjects who have had electroconvulsive treatment within the past 2 months.
- •8. Subjects with a positive drug screen for cocaine or other illicit drugs
- •9. Abnormal laboratory test results, vital signs or ECG results, unless based on investigator's judgment the findings are not medically significant or would not affect the trial results.
- •10. Rapid cyclers with more than 6 episodes in previous year
- •11. Subjects with uncontrolled hypo/hyperthyroidism
- •12. Subjects with uncontrolled hypertension or symptomatic hypotension or orthostatic hypotension.
- •13. Subject with epilepsy or history of seizures
- •14. Subjects who participated in a clinical trial within the last 60 days or who participated in more than 2 clinical trials within the past year.
- •15. Use of psychotropic medications (other than benzodiazepines) within 7 days of the baseline YMRS.
- •16. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
- •17. Subjects who received brexpiprazole in any prior clinical trial or currently taking commercially available brexpiprazole (Rexulti®).
研究者
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