NL-OMON56600RecruitingPhase 3
RESET-TRD; a Randomised trial on oral ESketamine compared to Electroconvulsive Therapy for patients with Treatment Resistant Depression - RESET-TRD
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 172
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- 18 years or older of age at screening;
- •- Sufficiënt 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
- •- Treatment Resistant Depression, 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.
Exclusion Criteria
- •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;
- •The presence of current moderate or severe dependence of alcohol or drugs 6
- •months within screening according to the DSM-5, not including tobacco-related
- •and caffeine-related disorders, ascertained by the MINI-plus interview at
- •Current use of a MAOI in excess of a daily dose of 60 mg;
- •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. In fertile
- •women, a urine pregnancy test will be performed prior to Phase 1 (screening)
- •and prior to Phase 2 (month 1) of the study. 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 absolute contra-indication for esketamine use (according to
- •the Summaries of Product Characteristics) or ECT (according to Dutch ECT
- •guidelines, Appendix A), namely pheochromocytoma, increased intracranial
- •pressure, intracranial surgery (< 6 months), a recent cerebrovascular accident
- •/ cerebral trauma, glaucoma, recent myocardial infarction (<6 months), unstable
- •angina pectoris or myocardial disease (New York Heart Association (NYHA) class
- •IV), aneurysmal vascular disease, severe hypertension, severe hyperthyroidism,
- •severe liver problems (Child-Pugh class C), severe kidney problems, acute
- •intermittent porphyria, severe upper airway infection, the use of medication
- •that esketamine interacts with on a major level, such as xanthine derivates
- •(aminophylline, theophylline) or previous hypersensitivity to esketamine or its
- •components;
- •Presence of any of the following relative contra-indications for esketamine
- •use (according to the Summaries of Product Characteristics) or ECT (according
- •to Dutch ECT guidelines, Appendix A), namely stable angina pectoris,
- •hypertension, myocardial infarction (> 6 months ago), intracranial process,
- •unstable cervical spine, carcinoid, severe COPD, severe obesity,
- •pseudocholinesterase deficiency, malignant hyperthermia and congenital muscle
- •diseases. Cardiovascular relative contra-indications will lead to consultation
- •with a colleague from the cardiology department. Thi
Investigators
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