jRCT2031200287已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Patients with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder as confirmed by the MINI
- •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
- •Medically stable during the prior three months
- •Participant is an outpatient with no psychiatric hospitalizations within the prior six months
- •PANSS-NSFS of 18 or higher
- •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)
- •Has an informant who is considered reliable by the Investigator
- •BMI between 18-40 kg/m2 inclusive
- •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
- •Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5
- •Any ESRS-A CGI subscore greater than or equal to 3
- •Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- •PANSS item G6 (depression) greater than or equal to 5
- •Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
- •A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
- •Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-
- •HCV antibody positive participants are eligible if HCV RNA is negative
- •Tardive dyskinesia that is moderate to severe or requires treatment
- •History of neuroleptic malignant syndrome
- •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
- •Clinically significant abnormalities in laboratory safety test results
- •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
- •On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening
- •History of clozapine treatment
- •History of treatment with electroconvulsive therapy (ECT)
- •Concomitant use of prohibited medications
- •Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates
- •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
- •Donation of blood over 400 mL within three months prior to screening
- •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
结局指标
主要结局
-
Efficacy BNSS
次要结局
未报告次要终点
研究者
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