NCT03669640终止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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 131
- 试验地点
- 44
- 主要终点
- Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
研究概览
简要总结
This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
- •Medically stable during the 3 months prior to study entry
- •Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
- •PANSS negative symptom factor score 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
- •Body mass index (BMI) between 18-40 kg/m2 inclusive
- •Female participants are eligible to participate if not pregnant, not breastfeeding and agree 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 of study entry (excluding nicotine or caffeine) as defined by DSM-5
- •Extrapyramidal symptom rating scale (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 Fridericia's Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (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 3 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
研究组 & 干预措施
Part A: Monotherapy
Experimental
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
干预措施: RO6889450 (Drug)
Part A: Monotherapy
Experimental
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
干预措施: Placebo (Drug)
Part B: Add-On Therapy
Experimental
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
干预措施: RO6889450 (Drug)
Part B: Add-On Therapy
Experimental
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
干预措施: Placebo (Drug)
结局指标
主要结局
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
时间窗: Baseline to Week 12
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78. The avolition/apathy subscale contains 2 items with a total score range of 0-12.
次要结局
- Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)(Baseline through Day 84)
- Clinical Global Impression Severity (CGI-S) Overall Scores(Baseline to week 12)
- Clinical Global Impression - Improvement (CGI-I) Overall Scores(Up to Week 12 (Day 84))
- Brief Negative Symptom Scale (BNSS) Total Scores(Baseline to week 12)
- Area Under the Curve at Steady State (AUCss) of RO6889450(Day 42)
- CGI-S Negative Symptoms (NS) Scores(Baseline to week 12)
- CGI-I Negative Symptoms Scores(Up to Week 12 (Day 84))
- PANSS Symptom Factor Scores(Baseline to week 12)
- Defeatist Performance Attitude Scale (DPAS) Scores(Baseline to week 12)
- Number of Participants With Suicidal Ideation or Behavior, and Self-injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline through Day 84)
- Positive and Negative Syndrome Scale (PANSS) Total Scores(Baseline to week 12)
- Maximum Serum Concentration (Cmax) of RO6889450(Day 42)
研究者
研究点 (44)
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