EUCTR2019-001692-37-DE进行中（未招募）1 期
Pharmacologic treatment augmentation in chronic depressionrandomized, controlled, double blinded, phase II study - ketamine plus CBASP
niversity Hospital Tuebingen0 个研究点目标入组 60 人开始时间: 2019年7月19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
- 60
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
- 性别
- All
入选标准
- •Age 18-64 at the time of study inclusion
- •Diagnosis of chronic depression: recurrent depressive
- •disorder, severe or moderate episodes (no full remission
- •between the episodes according to DSM-IV-TR (Falkai et
- •al., 2015) [no distinct depressive symptoms for at least two
- •months]) or acute depressive episode lasting two or more
- •Treatment resistance stage 2 according to Thase & Rush
- •(1997): Patient’s symptoms fulfil the criteria of chronic
- •depression listed above even after at least two appropriate
- •treatment attempts with two antidepressant medicaments
- •from two different effect categories
- •Patient’s symptoms fulfil the criteria of chronic depression
- •listed above even after executing at least 25 sessions of
- •psychotherapeutic treatment (psychoanalysis, depth
- •psychology-based psychotherapy or cognitive behaviour
- •Ability to give approval; Ability to understand and
- •voluntarily sign the informed consent form
- •Ability to adhere to the study visit schedule and other
- •protocol requirements
- •Contraception:
- •Male must agree to use a condom during any heterosexual
- •contact with Females of Childbearing Potential (FCBP) from
- •the first infusion until 65 days after the last infusion, even if he
- •has undergone a successful vasectomy, as well as to not
- •donate semen or sperm during this time period.
- •FCBP must agree to use two reliable forms of contraception
- •simultaneously or practice complete abstinence from
- •heterosexual contact from study start until 28 days after the
- •last infusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Acute substance misuse as primary diagnosis
- •Neurologic disorders: Stroke, cerebral ischemia, tumor,
- •cerebral infection, autoimmune disease
- •Disorders with increase of intracranial pressure, e.g. due
- •to head injury
- •Circulatory disturbance in the brain
- •Pregnant or lactating females
- •Participation in any clinical study or having taken any
- •investigational therapy, which would interfere with the
- •study’s primary end point
- •History of hypersensitivity to an investigational medicinal
- •product or to any drug with similar chemical structure or to
- •any excipient present in the pharmaceutical form of the
- •investigational medicinal product
- •Pretreatment with ketamine hydrochloride and/ or CBASP
- •Not or insufficiently treated hypertonia (arterial hypertonia
- •– systolic/ diastolic blood pressure higher than 150/ 100
- •mmHg at rest)
- •Not or insufficiently treated hyperthyrodism
- •Heartache due to insufficient blood circulation (unstable
- •angina pectoris) or heart muscle infarct (myocard infarct)
- •during the last six months
- •Increased intraocular pressure (glaucoma) and perforating
- •Interventions in the area of the upper respiratory passages
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