NCT05732311招募中不适用
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Berthold Langguth, MD, Ph.D.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- relapse (number of patients who have a relapse for depression)
研究概览
简要总结
This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
- •moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 >16 points)
- •response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment <11 points)
- •no concomitant psychotic symptoms.
- •no other relevant psychiatric disorder as assessed by the study physician
- •residence in Germany and German speaking that allows understanding of the information provided
- •patient is capable of giving consent
排除标准
- •fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
- •severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
- •current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
- •acute suicidality
- •pregnancy
- •current participation in another study
结局指标
主要结局
relapse (number of patients who have a relapse for depression)
时间窗: 33 weeks
50% increase of symptoms according to Hamilton depression rating scale
次要结局
- Major Depression Inventory(49 weeks)
- Columbia-Suicide Severity Rating Scale(49 weeks)
- Beck Anxiety Index(49 weeks)
- Hamilton Depression Rating Scale(49 weeks)
- World Health Organisation quality of life bref(49 weeks)
- clinical global impression(49 weeks)
- Global Assessment of Functioning(49 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Prof. Dr.
University of Regensburg
研究点 (2)
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