CTIS2023-506617-21-00进行中（未招募）1 期
A randomised, controlled trial to investigate the effect of a six-week intensified pharmacological treatment for major depressive disorder compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment. - INTENSIFY MDD
niversitair Medisch Centrum Utrecht0 个研究点目标入组 418 人开始时间: 2023年9月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •In- or out patients, at least 18 years of age up until 65., 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 (section 8.2.1)., Meeting diagnostic criteria for a primary diagnosis of major depressive disorder (without psychotic features), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2)., 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, as confirmed by a CGI-I =3., Subject 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 a score of =20 on the Montgomery Åsberg Depression Rating Scale (MADRS) - 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 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., 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., Subject has used (es)ketamine previously for the treatment of depressive symptoms., Subject has a known intolerance to (es)ketamine or to all TAU medication options., Meeting any of the contraindications for (es)ketamine or to all TAU medication options, as specified within the applicable SmPC, supported by clinically significant abnormal values on local laboratory tests, electrocardiogram (ECG) or physical examinations., 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., 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., 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)
研究者
相似试验
进行中（未招募）
1 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.Schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder or bipolar disorder type I and II (currently in a depressive episode)MedDRA version: 20.0Level: HLTClassification code: 10039620Term: Schizoaffective and schizophreniform disorders Class: 10037175MedDRA version: 21.1Level: LLTClassification code: 10081270Term: Major depressive disorder Class: 10037175MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873MedDRA version: 21.1Level: LLTClassification code: 10004936Term: Bipolar depression Class: 10037175CTIS2022-502185-24-00niversity Medical Center Utrecht1,254
进行中（未招募）
1 期
A randomised, controlled trial to investigate the effect of a six-week intensified pharmacological treatment for bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.Bipolar depressionMedDRA version: 21.1Level: LLTClassification code: 10004936Term: Bipolar depression Class: 10037175CTIS2023-506605-19-00niversitair Medisch Centrum Utrecht423
已完成
4 期
A study to investigate the real-life use of the Vannair SMART regime in adult asthma (the SMART study).AsthmaRespiratory - AsthmaACTRN12610000515099Medical Research Institute of New Zealand300
进行中（未招募）
4 期
A clinical study to investigate whether third-line treatments work better as a second-line treatment for people diagnosed with schizophreniaSchizophrenia, schizoaffective disorder or schizophreniform disorderMental and Behavioural DisordersISRCTN83479057niversity Medical Center Utrecht418
招募中
1 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.schizophrenia, schizoaffective disorder, schizophrenifom disorderMedDRA version: 21.1Level: PTClassification code: 10039647Term: Schizophreniform disorder Class: 100000004873MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873MedDRA version: 21.1Level: PTClassification code: 10039621Term: Schizoaffective disorder Class: 100000004873CTIS2023-506602-39-00niversitair Medisch Centrum Utrecht418