EUCTR2016-001715-21-BE进行中（未招募）1 期
Intravenous ketamine for Treatment Resistant Depression: Exploring biomarkers of response and relapse A double-blind, randomized controlled trial
Z Leuven0 个研究点目标入组 120 人开始时间: 2016年7月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Must be a man/woman of 18 or above
- •Meet the DSM-IV-TR diagnostic criteria for MDD, without psychotic features (DSM-IV 296.22, 296.23, 296.32, or 296.33) or BPD Type I or II (DSM-IV 296.89), currently in a depressed episode based upon clinical assessment at Screening.
- •Patients with BPD I or II should not be in a current mixed episode and should not have experienced mood incongruent psychotic features for at least 4 weeks.
- •Be medically stable on the basis of physical examination, 12-lead ECG, and vital signs, performed at Screening.
- •Be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study.
- •Patients should have an Inventory of Depressive Symptomatology-Clinician Rated (HAMD-17) total score = 17 at Screening and/or at day 1 (pre-dose)
- •Patients with major depressive disorder should have failed at least two adequate treatment courses (dose and duration) with antidepressant therapy, one of which is in the current episode. The definition of adequate antidepressant therapy can be reviewed in section 4.2..
- •Subjects recently started on a new antidepressant or a new adjunctive treatment (e.g., quetiapine, lithium, etc), are eligible provided none/minimal improvement of symptoms is seen after 4 weeks of dosing.
- •For patients who receive a higher/lower dose of an antidepressant medication that has previously been stable for at least 4 weeks, a duration of 2 weeks should lie between change of medication dose and screening.
- •For patients who recently stopped their antidepressant medication, a washout period of 14 days applies.
- •Patients may have received ECT (at least 2 weeks between last ECT and ketamine administration), or may be scheduled for ECT
- •Patients with bipolar depression (BPD) Type I or II can participate if they have had 2 different mood-stabilizing therapies or antidepressants in the past.
- •Patients with BPD I or II must have been taking a stable dose of a mood-stabilizing medication (see table in section 4.2.) ) for at least 4 weeks prior to ketamine infusion (day 8), dosed clinically to target the therapeutic range. If dose of the mood stabilizing medication was changed, they may participate given that no or minimal improvement is seen after 2 weeks of dosing.
- •Doses of current antidepressant therapies should remain the same for the duration of the study.
- •Benzodiazepines (Alprazolam, diazepam etc.) are permitted after consultation of the treating doctor. Daily doses of benzodiazepines or antipsychotic medication may vary if prescribed by the doctor but should be documented throughout the study period.
- •Inpatient or outpatient, and agrees to be admitted to the study site for IV ketamine administration and remain at the study site for 4 hours post-dose
- •Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (not on insulin) may participate in the study.
排除标准
- •Subject has a history of drug or alcohol abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria, except nicotine or caffeine, within 6 months before screening.
- •Subject has positive test result(s) for drugs of abuse (including opiates, cocaine, barbiturates, methadone, and amphetamine/methamphetamine) at screening or day 1 (predose).
- •Subjects with a positive test result at screening due to prescribed amphetamines or opioids may be enrolled in case no abuse history is known and no further indication for risk or abuse is evident to the researcher or known interactions occur with ketamine. Subjects with a positive alcohol breath test at screening may have the test repeated once during the screening phase, based on the investigator’s discretion. This determination, and the reason for permitting a repeat test, must be recorded in the subject's source documents and initialed by the investigator. A positive, repeat alcohol breath test is exclusionary.
- •Subject is currently taking > 4 psychotropic medications at day 1 (predose).
- •Has an autoimmune disorder such as Crohn’s disease, rheumatoid arthritis, psoriasis currently treated with/requiring treatment with immunomodulatory therapies ( interleukins, chemokines, cytokines or IMiDs). Participation depends on the study physician’s judgement.
- •Has any significant cardiovascular (including a history of myocardial infarction within 6 months prior to first dose administration), respiratory (including chronic obstructive pulmonary disease), neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases currently or within 6 months prior to the study; glaucoma; hypothyroidism or hyperthyroidism (a normal thyroid-stimulating hormone [TSH] is required at screening; subjects with hypothyroidism who are on stable treatment with normal TSH may participate) based on Screening examination.
- •Has uncontrolled hypertension (diastolic blood pressure > 90 mmHg), despite diet, exercise or a stable dose of an allowed antihypertensive treatment, at screening or day 8 (predose).
- •Has planned vaccination within 2 weeks prior to the first dose of study medication through 2 weeks after the last dose of study medication.
- •Has an acute infectious disease/current infection based on laboratory assessment at screening. Inclusion can still be permitted if the study doctor does not estimate any health risks associated with the use of ketamine and/or participation in the study.
- •Has received systemic corticosteroids within 21 days before day 1.
- •Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients (refer to SmPC)
- •Has contraindications to the use of ketamine per local prescribing information
- •Has received an investigational drug (including vaccines) or used an investigational medical device within 3 months before the planned start of study or are currently enrolled in an investigational study.
- •Female subjects only: is pregnant or breastfeeding.
- •Has any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study r
研究者
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