EUCTR2022-000581-17-BG招募中1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
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
- 性别
- All
入选标准
- •1. Male and female participants, ages 18 to 65 years, inclusive, at the time of signing the ICF
- •2. Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders version 7.0.2
- •3. CGI-S =4 (moderately to severely ill) at the time of signing the ICF and Baseline
- •4. PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. Additionally, participants must meet a score of =4 (moderate or greater) for =2 of the following Positive Scale items at the time of signing the ICF and at Baseline:
- •Positive Scale Item 1 (delusions)
- •Positive Scale Item 2 (conceptual disorganization)
- •Positive Scale Item 3 (hallucinatory behavior)
- •Positive Scale Item 6 (suspiciousness/persecution)
- •5. Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
- •Participant requires hospitalization for this acute exacerbation or relapse of symptoms
- •If participant is already an inpatient at the time of signing the ICF, has been hospitalized for =14 days for the current episode of psychosis at the time of signing the ICF, excluding hospitalization for psychosocial reasons
- •6. Scores as follows (normal to mild symptoms) at the time of signing the ICF and Baseline (Day 1):
- •All individual items of the SAS <2
- •All individual items (Items 1-7) of the AIMS <2
- •Clinical global assessment item of the BARS <3
- •7.Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
- •8.Resides in a stable living environment as demonstrated by the ability to provide contact information for themselves and/or family/friend/caregiver.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Current DSM-5 diagnosis other than schizophrenia including, but not limited to, intellectual disability; schizoaffective disorder; major depressive disorder; schizophreniform disorder; psychotic depression; bipolar disorder; post-traumatic stress disorder; generalized anxiety disorder, obsessive compulsive disorder, eating disorders (bulimia, anorexia), or other anxiety disorders as a primary diagnosis (note: anxiety symptoms secondary to schizophrenia are allowed); delirium, dementia, amnestic, or other cognitive disorders.
- •Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory.
- •Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
- •Additional excluded conditions include borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •2.Any of the following:
- •Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)
- •History of response to clozapine treatment only or failure to respond to clozapine treatment for schizophrenia
- •3.Any of the following regarding history of schizophrenia:
- •Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
- •Presenting with an initial diagnosis of schizophrenia
- •Presenting for the first time with an acute psychotic episode requiring treatment
- •4.Reduction (improvement) in PANSS total score of =20% between Screening and Baseline.
- •5.Either of the following:
- •History of tardive dyskinesia
- •Extrapyramidal symptoms that required medication within 6 months prior to signing the ICF
研究者
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