CTRI/2020/09/027537招募中2 期
A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication.
ewron Pharmaceuticals SpA0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Psychiatric
- •3. Meets current DSM-5 criteria for schizophrenia. Other psychiatric disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia. [see Exclusion criteria below]
- •4. Has been diagnosed with schizophrenia within the past 10 years.
- •5. Has shown treatment-resistance according to psychiatric history, with the last failed treatment documented in the patientâ??s clinical records. â??Treatment-resistant Schizophreniaâ?? (TRS) is defined as a persistence of significant clinical symptoms despite adequate doses of two standard antipsychotic medications (other than clozapine) from two different chemical classes, including at least one atypical antipsychotic, for at least 6 weeks of treatment each. The last failed treatment trial must be documented.
- •6. Has a Clinical Global Impression â?? Severity of disease (CGI-S) rating of moderately ill to severely ill (score of 4 to 6 [scale 1-7]).
- •7. Has a PANSS total score >= 70 at screening and baseline.
- •8. Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6 (Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6 (Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content).
- •9. Has a Global Assessment of Functioning (GAF) scale total score <= 50.
- •10. Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a stable dose (minimally for 4 weeks prior to screening) at a minimal recommended therapeutic or higher dose of one antipsychotic (atypical or typical, other than clozapine). Current use of quetiapine at a dose of 150 mg or less at night as a soporific will not be considered polypharmacy.
- •11. Current level of symptoms has been present for at least one month, but not exceeding one year.
排除标准
- •Psychiatric
- •1. DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia (CDSS); a score of 7 or higher will be exclusionary).
- •2. History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of â??moderateâ?? or â??severeâ??, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine or caffeine dependence is acceptable; and patients testing positive for THC on the urine drug screen will not be excluded from the study unless there is evidence of toxic psychosis.
- •3. Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric daycare, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
- •4. Has a PANSS total score > 90 or a CGI-S rating of 7 (among the most extremely ill patients).
- •5. History or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study.
- •6. Known suicidal risk, or a suicide attempt within the past 2 years, as assessed by the CDSS and/or by psychiatric history.
- •7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia.
研究者
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