2022-502185-24-00撤回3 期
A randomised, controlled trial to investigate the effect of a four/six week intensified pharmacological treatment for schizophrenia, major depressive disorder and bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 945
- 试验地点
- 12
- 主要终点
- Change in symptom severity total score from baseline (visit 2) to four-weeks (MDD)/six-weeks (SZ/BD) (visit 4). For SZ, this is measured using the Positive And Negative Syndrome Scale. For MDD and BD, Montgomery Asberg Depression Rating Scale is applied.
研究概览
简要总结
The primary objective is to compare the treatment response, expressed as mean change in symptom severity under an early-intensified pharmacological treatment to that under treatment as usual, in subjects who had a first-time treatment failure on their first-line treatment. This will be investigated in the diagnoses schizophrenia, schizoaffective disorder, schizophreniform disorder (SZ study sample), major depressive disorder (MDD study sample) and bipolar depression (bipolar disorder I/II currently in a depressive episode; BD study sample). The treatments differ between the three study sample, but the overarching goal is equal.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomisation during the entire study
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •In- or out patients, at least 18 years of age up until
- •Being willing and able to provide written informed consent. If unable, having a legal guardian to provide written informed consent is allowed (participant’s opinion will also be considered in these cases).
- •Female subjects of child bearing potential must be willing to ensure that they use effective contraception during the trial and as per the requirements in the protocol (section 8.2).
- •Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features) or bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-
- •The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview
- •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.
- •Subject has failed on current psychopharmacological treatment of current episode of SZ/MDD/BD, as confirmed by a CGI-I ≥
- •Subject and clinician intend to change pharmacotherapeutic treatment.
- •A minimum symptom severity threshold needs to be present (moderate level; more details in the protocol section 6.2) and subject needs to experience functional impairment.
排除标准
- •Being pregnant or breastfeeding.
- •Current active suicidal ideation within the last 2 weeks, defined as a score of 1 or higher on CDSS question 8, followed by an assessment by the treating clinician who determines it is not safe for the patient to participate in the study.
- •Subject meets criteria for current alcohol and/or drugs substance use disorderdependency, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). For all study samples: Nnicotine 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.
- •Subjects who are admitted in the (psychiatric) clinic due to a court or administrative order are not allowed to participate in the study.
- •For the SZ sample only: schizophrenia subjects cannot meet the modified Andreasen criteria for remission.
- •For the BD sample only: a score of 8 or higher on the Young Mania Rating Scale in order to exclude subjects with predominant manic symptoms or mixed symptoms.
- •Subject has failed previously on the EIPT study medication (i.e. SZ: clozapine; MDD: esketamine intranasal/(es)ketamine IV *) or the TAU treatment for BD (quetiapine) due to inefficacy. Treatment duration as ≥ 4 weeks within an efficacious dose range according to the SmPC.
- •Subject has a known intolerance to clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only) or to all medication and excipients options for a study sample (related to the TAU treatment arms).
- •Meeting any of the contraindications of clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only *), or to all medication options for a study sample (related to the TAU treatment arms), as specified within the applicable SmPC.
- •Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit
- •Subject currently uses more than the allowed psychotropic concomitant medication and needs to stay on this medication during the study.
- •Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
研究组 & 干预措施
-
Active Comparator
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Change in symptom severity total score from baseline (visit 2) to four-weeks (MDD)/six-weeks (SZ/BD) (visit 4). For SZ, this is measured using the Positive And Negative Syndrome Scale. For MDD and BD, Montgomery Asberg Depression Rating Scale is applied.
Change in symptom severity total score from baseline (visit 2) to four-weeks (MDD)/six-weeks (SZ/BD) (visit 4). For SZ, this is measured using the Positive And Negative Syndrome Scale. For MDD and BD, Montgomery Asberg Depression Rating Scale is applied.
次要结局
- The secondary endpoints are already described in the secondary objectives
研究者
Dr. Inge Winter
Scientific
University Medical Center Utrecht
研究点 (12)
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