JPRN-jRCT2031200287已完成2 期
PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF RO6889450 (RALMITARONT) IN PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AND NEGATIVE SYMPTOMS
Clinical trials information0 个研究点目标入组 220 人开始时间: 2021年1月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
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
- 年龄范围
- >= 18age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •1. Patients with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder as confirmed by the MINI
- •2. Stable treatment with a D2/5HT2A antagonist or pure D2 antagonists, or a D2 partial agonist for a minimum of six months and receiving no more than two antipsychotics
- •3. Medically stable during the prior three months
- •4. Participant is an outpatient with no psychiatric hospitalizations within the prior six months
- •5. PANSS-NSFS of 18 or higher
- •6. The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control)
- •7. Has an informant who is considered reliable by the Investigator
- •8. BMI between 18-40 kg/m2 inclusive
- •9. A woman is eligible to participate if she is not pregnant, not breastfeeding, and agrees to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug
排除标准
- •1. Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5
- •2. Any ESRS-A CGI subscore greater than or equal to 3
- •3. Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- •4. PANSS item G6 (depression) greater than or equal to 5
- •5. Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
- •6. A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
- •7. Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative
- •8. Tardive dyskinesia that is moderate to severe or requires treatment
- •9. History of neuroleptic malignant syndrome
- •10. Average triplicate QTcF interval greater than 450 msec for males and 470 msec for females or other clinically significant abnormality on screening ECG based on centralized reading
- •11. Clinically significant abnormalities in laboratory safety test results
- •12. Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study
- •13. On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening
- •14. History of clozapine treatment
- •15. History of treatment with electroconvulsive therapy (ECT)
- •16. Concomitant use of prohibited medications
- •17. Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates
- •18. Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration
- •19. Donation of blood over 400 mL within three months prior to screening
- •20. Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Effects of RO6889450 (Ralmitaront) in Patients with Schizophrenia or Schizoaffective Disorder and Negative SymptomsEUCTR2020-004752-16-ESF. Hoffmann-La Roche Ltd220
进行中（未招募）
1 期
A study to evaluate the benefit and safety of Luspatercept (ACE-536) in adults with Beta-Thalassemia who do not require regular red blood cell tranfusionson transfusion dependent ß-thalassemiaMedDRA version: 20.0Level: LLTClassification code 10074356Term: Non-transfusion dependent thalassemiaSystem Organ Class: 100000004850EUCTR2015-003225-33-ITCELGENE CORPORATIO150
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESPAIN DUE TO BONE METASTASESMedDRA version: 13.1Level: LLTClassification code 10049038Term: Metastatic bone painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005181-31-ATPfizer Inc., 235 East 42nd Street, New York, NY 1001758
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESPAIN DUE TO BONE METASTASESMedDRA version: 9.1Level: LLTClassification code 10049038Term: Metastatic bone painEUCTR2008-005181-31-HUPfizer Inc., 235 East 42nd Street, New York, NY 1001760
进行中（未招募）
不适用
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASESEUCTR2008-005181-31-LVPfizer Inc., 235 East 42nd Street, New York, NY 1001758