ACTRN12623000500651招募中Unknown
Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder: Understanding the Mechanism of Action.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 55 Years（—）
- 性别
- All
入选标准
- •To be eligible for participation in the study, participants must meet all of the following criteria:
- •1)Diagnosis – Participant is diagnosed with Obsessive Compulsive Disorder (OCD) according to DSM-5 Diagnostic Criteria.
- •2)Severity – Participant has a Yale Brown Obsessive Compulsive Scale (Y-BOCS) score of more than or equal to 24, measured twice at least 2 weeks apart.
- •3)Chronicity – Duration of illness greater than 5 years.
- •4)Treatment Refractoriness – No or insufficient response following at least
- •2 treatment trials with a Selective Serotonin Reuptake Inhibitor (SSRI), at maximum tolerated dosage for at least 12 weeks, plus
- •1 treatment trial with clomipramine at maximum tolerated dosage for at least 12 weeks, plus
- •1 augmentation trial with an atypical antipsychotic for 8 weeks in combination with one of the above mentioned drugs, plus
- •1 attempted psychotherapy trial (exposure and response prevention or ERP), confirmed by psychotherapist.
- •5)Aged between 20-55 years.
- •6)Participant is male or non-pregnant female adequately protected by conception. Females of childbearing potential must use an acceptable method of birth control for the duration of participation in the trial. Abstinence is an acceptable means of birth control.
- •7)Participant is able to comply with all testing and follow-up visit requirements defined by the Study Protocol.
- •8)Participant has voluntarily signed an informed consent.
- •9)Participant’s medication regimen has remained stable for at least 6 weeks prior to study enrolment.
排除标准
- •Participants with any of the following will not be eligible for enrolment:
- •1)A lifetime diagnosis of psychotic disorder, current or past (such as schizophrenia, schizoaffective disorder or delusional disorder).
- •2)Diagnosed manic episode within the last 3 years.
- •3)Clinical history consistent with severe personality disorder of any type.
- •4)Current, or unstably remitted substance abuse disorder, the latter being defined by history consistent with substance dependence in the last 12 months, or abuse in the last 6 months, other than nicotine dependence or abuse.
- •5)Participant is at high risk of suicide:
- •Has made a suicide attempt within the previous 12 months that required medical treatment, or
- •Has made two suicide attempts in the past 12 months, or
- •Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study, or
- •Is likely to attempt suicide within the next six months, in the investigator’s opinion.
- •6)Current clinically-significant medical illness or neurological disorder, excluding tic disorder.
- •7)Clinically-significant abnormality on pre-operative MRI.
- •8)Any labelled contraindication to having DBS surgery, and/or inability to undergo pre-operative MRI.
- •9)Pregnancy.
- •10)Participant has received general anaesthesia in a 30 day period prior to the DBS implantation.
- •11)Participant is currently enrolled in another investigational study or is using another investigational device.
研究者
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