EUCTR2020-000094-24-BG进行中（未招募）1 期
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of 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
- 500
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. Meet the diagnostic criteria for schizophrenia according to the DSM-5 ™.
- •2. Be currently experiencing active phase symptoms of schizophrenia (DSM-5 ™ Criterion A).
- •3. Have an illness duration for schizophrenia of at least 1 year.
- •4. Be confirmed to be experiencing an acute episode of schizophrenia, as evidenced by ALL of the following:
- •a. Onset of the current acute episode is =6 weeks prior to screening
- •b. Current symptoms represent a marked and substantial worsening compared with the participant’s usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability
- •c. In need of increased psychiatric attention to treat worsening acute episode symptoms
- •5. Have a minimum PANSS total score of =80 at screening.
- •6. Have a score of =4 (moderate) in 2 or more of the following items in the positive subscale of the PANSS at screening: delusions, hallucinations, conceptual disorganization, suspiciousness; at least 1 must be hallucinations or delusions.
- •7. Have a CGI-S score of =4 (moderately ill) at screening and baseline.
- •8. Be able to taper off psychotropic medications (including antipsychotics, antidepressants and mood stabilizers) without significant destabilization or increased suicidality in the opinion of the investigator with the last dose taken no later than the evening prior to the baseline visit (Visit 2/Day 1; the dosing cycle of depot neuroleptics must end no later than the day prior to baseline), with the exception that the last dose of past MAO
- •inhibitors cannot be within 30 days of the screening visit.
- •9. Have had a positive response to antipsychotic medication (other than clozapine) during at least 1 period of treatment for a prior psychotic episode.
- •10. Be male or female from 18 years to 56 years of age inclusive, at the time of signing the informed consent.
- •11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •- Not a WOCBP
- •- A WOCBP and:
- •* uses a contraceptive method that is highly effective during the intervention period and for at least 14 days after the last dose of study intervention
- •* Has a negative highly sensitive pregnancy test ([urine or serum] as
- •required by local regulations) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •* Abstains from breastfeeding during the study intervention period and for review of medicalat least 7 days after study intervention.
- •* Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •12. Provide documented informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •13. Have a level of decision-making capacity needed to make a meaningful choice about whether to participate in the study.
- •14. Be willing and considered able by the investigator to participate in protocol assessments, including recordings of interviews, adhere to dose and visit schedules, study procedures and restrictions; this includes the ability to participate in all study procedures witho
排除标准
- •1. Has a primary current diagnosis other than schizophrenia or a
- •comorbid diagnosis (for example, major depression) that is primarily
- •responsible for the current symptoms and functional impairment.
- •2. Meets criteria for moderate to severe substance use disorder currently or within past 6 months prior to screening.
- •3. Has a known history of the following:
- •a. Borderline personality disorder, antisocial personality disorder, or
- •bipolar disorder
- •b. Traumatic brain injury causing ongoing cognitive difficulties,
- •Alzheimer's disease or another form of dementia, or any chronic organic disease of the central nervous system
- •c. Intellectual disability of a severity that would impact the ability of the participant to participate in the study
- •4. Has a current diagnosis of a psychotic disorder (other than
- •schizophrenia), or a behavioral disturbance thought to be substanceinduced or due to substance abuse.
- •5. Has moderate or severe tardive dyskinesia according to the
- •investigator.
- •6. Is or was under involuntary commitment for the current acute
- •episode, because the participant is considered a danger to themselves or others.
- •7. Has committed an act of violence (assaultive behavior) = 2 years prior to the screening visit.
- •8. Has a body mass index (BMI) <18.5 kg/m2.
- •9. Has a risk factor for QTc prolongation as defined by:
- •a. A known history or current evidence of QTc interval > 470 msec (men) or > 480 msec (women)
- •b. A known history of risk factors for Torsades de Pointes
- •10. Has known renal disease or is experiencing renal insufficiency as
- •defined by: eGFR of <50 mL/min/1.73m2 [as measured by CKD-EPI formula]
- •11. Has known history of chronic convulsive disorder (eg, epilepsy or
- •seizure disorder) except febrile seizures of childhood.
- •12. Has a history of neuroleptic malignant syndrome.
- •13. Has a history of malignancy =3 years prior to signing informed
- •consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •14. Is at imminent risk of self-harm or harm to others.
- •15. Has a history of 3 or more significant allergies (including latex
- •allergy) to prescription or nonprescription drugs or food.
- •16. Has a known allergy or intolerance to risperidone or any of its active or inert ingredients.
- •17. Has hypothyroidism, diabetes, high blood pressure, cardiovascular condition, respiratory condition or other chronic medical conditions unless the condition is stable; the prescribed dose and regimen of medication are stable for = 3 months prior to screening; and there are no expected changes in comedication during the study.
- •18. Has a history of treatment resistance exhibited by any of the
- •a. No or minimal response to at least 2 periods of treatment lasting 6
- •weeks or longer, with antipsychotic agents (from at least 2 different
- •chemical classes) at the maximally tolerated dose.
- •b. History of ECT treatment for treatment resistant schizophrenia within the past 6 month
- •c. Past or current use of clozapine as single or adjunctive therapy for
- •schizophrenia within the past 5 years
- •19. Is currently taking and benefiting from a moderate or strong CYP3A
- •and/or CYP2C9 inhibitors and inducers and/or CYP2B6 sensitive
- •substrates.
- •20. Is currently taking and benefiting from strong CYP2D6 inhibitors.
- •21. Is currently participating in or has participated in another clinical
- •study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and no more than 2 studies i
研究者
相似试验
招募中
2 期
Phase 2B Study of MK-8189 in Participants with an Acute Episode of SchizophreniaSchizophreniaJPRN-jRCT2071200096Tanaka Yoshiyuki40
进行中（未招募）
1 期
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2020-000094-24-HRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.576
进行中（未招募）
1 期
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2020-000094-24-LVMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.576
进行中（未招募）
1 期
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2020-000094-24-PLMerck Sharp & Dohme LLC500
进行中（未招募）
不适用
A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With ?On-Off? or ?Wearing-Off? Effects Associated With Parkinson?s Disease - NDMedDRA version: 9.1Level: HLGTClassification code 10028037Parkinson?s deseaseMedDRA version: 9.1Level: PTClassification code 10030312EUCTR2008-004447-11-ITVECTURA LIMITED66