2023-506602-39-00招募中4 期
A randomised, controlled trial to investigate the effect of a six-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.
Universitair Medisch Centrum Utrecht12 个研究点 分布在 4 个国家目标入组 310 人开始时间: 2023年12月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 12
- 主要终点
- Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
研究概览
简要总结
The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as in symptom severity at six weeks and changes in symptom severity from baseline as measured through the Positive And Negative Syndrome Scale (PANSS) 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 for schizophrenia, schizoaffective or schizophreniform disorder.
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（65+ Years, 18-64 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. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
- •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 or 2 (before; randomisation; section 8.2).
- •Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-
- •The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
- •Subject experiences his/her first treatment failure due to lack of efficacy in the current episode, as confirmed by CGI-I ≥3; this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics.
- •Patient and clinician intend to change pharmacotherapeutic treatment.
- •A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment. - 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 - Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).
排除标准
- •Being pregnant or breastfeeding.
- •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 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.
- •Subjects with active suicidal ideation with some intent to act, without specific plan (“Yes” to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent (“Yes” to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study
- •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 and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
- •Subjects that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations.
- •Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
- •Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Subjects who meet the modified Andreasen criteria for remission.
- •Subject has used clozapine in the past.
- •Subject has a known intolerance to clozapine or to all TAU medication options.
结局指标
主要结局
Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
次要结局
- Change from baseline (visit 2) in PANSS subscale scores (positive, negative and general) at visit 4; EIPT vs TAU.
- 2.a. Change from baseline (visit 2) in the severity sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU. 2.b. Improvement sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) in total Hospital Anxiety and Depression Scale (HADS) total score and anxiety and depression subscales at visit 4; EIPT vs TAU.
- Change from baseline (visit 2) in quality of life and functioning measures (Q-LES-Q-SF, LAPS, QLS-100 and SDS) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) on Trail Making Test, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test as well as the Perceived Deficits Questionnaire at visit 4; EIPT vs TAU.
- Presence of symptomatic remission at visit 4; EIPT vs TAU. Remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) 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.
- Presence of reported adverse events (related and unrelated to treatment) as measured through General Assessment of Side Effects Scale (GASE) and reported spontaneously througout the study; EIPT vs TAU.
- Concomitant medication use throughout the study; EIPT vs TAU.
- Premature treatment discontinuation before visit 4 and time to treatment discontinuation and reported reason of discontinuation; EIPT vs TAU.
- Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU.
研究者
Dr. Inge Winter
Scientific
Universitair Medisch Centrum Utrecht
研究点 (12)
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