2024-512478-86-00招募中2 期
Pharmacologic treatment augmentation in chronic depression “randomized, controlled, double blinded, phase II study”
Universitaetsklinikum Tuebingen AöR2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Depressive symptoms will be assessed by the Montgomery Asberg Depression Rating Scale(MADRS, Schmidtke et al., 1988), a standardized and widely used clinician rating scale. TheMADRS will be conducted by a rater independent of the the treatment team and blind totreatment condition.
研究概览
简要总结
Reduction of depressive symptoms (assessed with Montgomery–Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of and six weeks after end of combination treatment (Δ t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18-64 at the time of study inclusion Diagnosis of chronic depression: recurrent depressivedisorder, severe or moderate episodes (no full remissionbetween the episodes according to DSM-IV-TR (Falkai etal., 2015) [no distinct depressive symptoms for at least twomonths]) or acute depressive episode lasting two or moreyears Treatment resistance stage 2 according to Thase & Rush(1997): Patient’s symptoms fulfil the criteria of chronicdepression listed above even after at least two appropriatetreatment attempts with two antidepressant medicamentsfrom two different effect categories Patient’s symptoms fulfil the criteria of chronic depressionlisted above even after executing at least 12 sessions ofpsychotherapeutic treatment (psychoanalysis, depthpsychology-based psychotherapy or cognitive behaviourtherapy) Ability to give approval; Ability to understand and voluntarilysign the informed consent form Ability to adhere to the study visit schedule and otherprotocol requirements Contraception:
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 tohead injury Circulatory disturbance in the brain Pregnant or lactating females Participation in any clinical study or having taken anyinvestigational therapy, which would interfere with thestudy’s primary end point Epilepsy History of hypersensitivity to an investigational medicinalproduct or to any drug with similar chemical structure or toany excipient present in the pharmaceutical form of theinvestigational medicinal product Pretreatment with ketamine hydrochloride (Ketamin Inresa2 ml) and/ or CBASP Not or insufficiently treated hypertonia (arterial hypertonia –systolic/ diastolic blood pressure higher than 150/ 100mmHg at rest) Not or insufficiently treated hyperthyrodism Heartache due to insufficient blood circulation (unstableangina pectoris) or heart muscle infarct (myocard infarct)during the last six months Increased intraocular pressure (glaucoma) and perforatingeye injury Interventions in the area of the upper respiratory passages
结局指标
主要结局
Depressive symptoms will be assessed by the Montgomery Asberg Depression Rating Scale(MADRS, Schmidtke et al., 1988), a standardized and widely used clinician rating scale. TheMADRS will be conducted by a rater independent of the the treatment team and blind totreatment condition.
Depressive symptoms will be assessed by the Montgomery Asberg Depression Rating Scale(MADRS, Schmidtke et al., 1988), a standardized and widely used clinician rating scale. TheMADRS will be conducted by a rater independent of the the treatment team and blind totreatment condition.
次要结局
未报告次要终点
研究者
CRO
Scientific
Universitaetsklinikum Tuebingen AöR
研究点 (2)
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