NL-OMON51415尚未招募3 期
A randomised non-inferiority trial of esketamine versus electroconvulsive therapy in treatment-resistant depression - RESET-TRD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
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 99（—）
入选标准
- •18 years or older of age at screening;
- •Sufficient level of spoken and written Dutch;
- •Ability to freely provide written informed consent prior to study
- •participation;
- •Current DSM-5 diagnosis of MDD without psychotic symptoms, ascertained by
- •the Mini International Neuropsychiatry Interview (MINI-plus);
- •At least moderate to severe depression, defined by a MADRS total score >= 20;
- •Indication for ECT treatment for the treatment of the current depressive
- •TRD, defined as non-response to (or established non-tolerability of)
- •treatment with at least two different antidepressants plus an augmentation step
- •such as lithium, mirtazapine or quetiapine during lifetime, all prescribed in
- •an adequate dose (i.e. defined daily dose) for at least four weeks;
- •Patients agree with initial clinical admission and subsequent
- •daycare/outpatient treatment.
排除标准
- •Prior or current bipolar disorder, schizophrenia spectrum, other psychotic
- •disorders, current MDD with psychotic features (previous MDD with psychotic
- •features is allowed if the current episode is non-psychotic). All diagnoses
- •according to DSM-5, assessed with MINI-plus interview at screening;
- •Current use of a MAOI in excess of a daily dose of 60 mg;
- •The presence of current moderate or severe dependence of alcohol or drugs at
- •screening according to the DSM-5, not including tobacco-related and
- •caffeine-related disorders, ascertained by the MINI-plus;
- •Recent (within the last four weeks of screening) or current use of cannabis
- •or any other non-prescribed psychoactive compounds, including Saint John*s
- •wort, assessed at screening;
- •Relevant neurological disorders, such as dementia or epilepsy;
- •Recent (within the last four weeks of screening) change of treatment with
- •antidepressants;
- •Planned changes in antidepressant treatment during phase 1 of the study, not
- •being part of the standard practice of ECT treatment like change in lithium or
- •anti-epileptics;
- •Active suicidal plans, defined by a score higher than 5 (explicit plans for
- •suicide when there is an opportunity or active preparations for suicide) on the
- •MADRS*s item for suicidal ideation;
- •(Suspected) pregnancy, lactation, or insufficient contraception. If there is
- •any doubt, a pregnancy test is performed;
- •Current use of benzodiazepine and benzodiazepine-like agents (zolpidem,
- •zopiclone) in excess of 3 mg lorazepam or an equivalent per day;
- •Recent (within the last four weeks of screening) start or change in the use
- •of somatic medication that commonly affects mood, like corticosteroids;
- •Previous treatment with ECT or esketamine during the current depressive
- •Presence of any contra-indication for esketamine use, such as increased
- •intracranial pressure, cerebrovascular accident, cerebral trauma, glaucoma,
- •recent myocardial infarction (<6 months), or other relevant cardiac problems
- •like unstable angina pectoris or myocardial disease, aneurysmal vascular
- •disease, severe hypertension, severe hyperthyroidism, severe liver problems,
- •severe kidney problems, the use of medication that esketamine interacts with on
- •a major level, such as monoamine oxidase inhibitors and xanthine derivates
- •(aminophylline, theophylline) or previous hypersensitivity to esketamine or its
- •components; While not exclusion criteria, enrolling a potential participant who
- •meets any of the relative contra-indications for esketamine use according to
- •the Summary of Product Characteristics (SPC), like clinically significant
- •respiratory conditions, will be decided based on a per patient assessment of
- •potential risk;
- •Presence of any contra-indication for ECT according to the Dutch Richtlijn
- •Electroconvulsietherapie (2010) (appendix A). While not exclusion criteria,
- •enrolling a potential participant who meets any of the relative
- •contra-indications for ECT according to the Richtlijn Electroconvulsietherapie
- •will be decided based on a perpatient assessment of potential risk;
- •Mental incompetence to fully understand the informed consent of this study,
- •based on the judgment of the general practitioner or treating psychiatrist of
- •the participant;
- •Inability to understand or comply with study requirements, as judged
研究者
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