ISRCTN83479057进行中（未招募）4 期
A randomised, controlled trial to investigate the effect of a 6-week intensified pharmacological treatment for schizophrenia compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 418
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. In- or out patients, at least 18 years of age up until 70 years
- •2. Being willing and able to provide written informed consent. If unable and allowed by local laws and regulations, having a legal guardian to provide written informed consent is allowed (subject’s opinion will also be considered in these cases).
- •3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 (section 8.2 of protocol).
- •4. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
- •5. Subject currently experiences his/her first treatment failure due to lack of efficacy; this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within the dose range as specified in the Summary of Product Characteristics (SmPCs). *
- •6. Subject has failed on current psychopharmacological treatment of current episode of SZ, as confirmed by a CGI-I =3. **
- •7. Subject and clinician intend to change pharmacotherapeutic treatment. ***
- •8. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment.
- •8.1. The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5.
- •8.2. Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).
- •* If subjects already stopped the previous pharmacological treatment due to lack of efficacy, the stopped treatment should still be the first treatment failure on a first-line pharmacotherapeutic agent prescribed for at least 4 weeks within the dose range as specified in the SmPC.
- •** Preferably, the CGI-I is obtained from the (previous) treating physician or clinical team, who decided that there is a treatment failure. If this is not possible, it is accepted to obtain this information from the subject.
- •*** Change is considered a full change (tapering off previous treatment [if not already stopped] and initiating the new treatment as indicated by the randomisation arm).
排除标准
- •1. Being pregnant or breastfeeding.
- •2. Subject has failed previously on clozapine due to inefficacy. Treatment duration as =4 weeks within an efficacious dose range according to the SmPC.
- •3. Subject has a known intolerance to clozapine or to all TAU medication options.
- •4. Meeting any of the contraindications of clozapine or to all TAU medication options, as specified within the applicable SmPC. *
- •5. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
- •6. Subject currently uses more than the allowed psychotropic concomitant medication and needs to stay on this medication during the study. **
- •7. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject’s ability to participate in the trial.
- •8. Moderate or high suicidal ideation within the last 2 weeks, defined as a score of 9 or higher on Module B (Suicidality) of the Mini International Neuropsychiatric Interview (MINI v7.0.2) ***
- •9. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Moderate and severe alcohol and/or cannabis use disorder are not allowed.
- •10. Subjects who are admitted in the (psychiatric) clinic due to a court or administrative order are not allowed to participate in the study.
- •11. Subjects who meet the modified Andreasen criteria for remission. ****
- •* Some SmPCs specify precautions. These are not considered as contraindications (in this trial or in clinical practice). If investigators take precautionary measures, participants can still be initiated on the medication, as this is in line with clinical practice and the SmPC.
- •** Allowed concomitant medication can be found in Section 8.1 of protocol. For clarity: if the participant is currently on a first-line treatment that is not efficacious and will be switched within the study, this medication does not count for this criterion. This criterion focusses on other, psychotropic concomitant medication (not for the primary diagnosis).
- •*** The decision to include the participant is at the clinician’s discretion. If the score on module B is lower than 9, but the clinician still considers the risk of a suicide attempt too high, it still can be decided to exclude the participant.
- •****The Andreasen criteria are defined as:
- •Low scores (=3) on eight diagnostically relevant symptoms in the Positive and Negative Syndrome Scale (PANSS): P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content. Originally, this is coupled with a time criterion (duration of 6 months). The time criterion is not applicable in the study, because it is not feasible as this should have been reported in clinical practice where PANSS is not performed.
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