ACTRN12615001309572已完成未知
Deep Brain Stimulation for Patients with Treatment-Resistant Obsessive Compulsive Disorder: Identifying electrophysiological biomarkers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
Obsessive Compulsive Disorder (OCD) is a psychiatric condition that affects nearly 1-2% of the population. Its treatment is symptomatic and its symptoms have severe effects on quality of life. However a large number of patients are not responsive to the pharmacotherapy. This trial is to use Deep Brain Stimulation, an established therapy for movement disorders to manage the symptoms of treatment resistant OCD. We treated 9 patients in a randomised double blind trial. with very good outcomes
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
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •To be eligible for participation in the study, patients must meet all of the following criteria:
- •1. Diagnosis - Patient is diagnosed with primary obsessive-compulsive disorder (OCD) according to DSM-IV diagnostic criteria derived from the SCID.
- •2. Severity - Patient 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 an 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 antipsychotic for 8 weeks in combination with the one of the abovementioned drugs plus
- •* 1 CBT trial (Exposure and response prevention or ERP), confirmed by patient or psychotherapist, for an adequate number of sessions as determined by a neuropsychiatrist.
- •5.Patient is aged between 18-70 years.
- •6. Patient is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control. Abstinence is an acceptable means of birth control.
- •7. Patient is able to comply with all testing and follow-up visit requirements defined by the Study Protocol.
- •8. Patient has voluntarily signed an informed consent in accordance with institutional policies.
- •9. Patient’s medication regime has remained stable for at least 6 weeks prior to study inclusion.
排除标准
- •Patients 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 disorders).
- •2. Diagnosed manic episode within the last 3 years.
- •3. Clinical history consistent with severe personality disorder.
- •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. Current clinically significant medical illness or neurological disorder, excluding tic disorder.
- •6. Clinically significant abnormality on pre-operative MRI.
- •7.Any labelled contraindication to having DBS surgery, and/ or inability to undergo preoperative MRI.
- •8. Pregnancy.
- •9. Patient meets any of the following:
- •* 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.
- •10. Patient had received general anesthesia in a 30 day period prior to DBS implantation.
- •11. Patient is currently enrolled in another investigational study or is using another investigational device.
- •12. Patient has a history of, or evidence of, significant brain malformation or significant head injury or clinically apparent cerebral vascular events, or prior brain surgery such as cingulotomy.
- •13. Patient has a cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
研究者
相似试验
进行中（未招募）
不适用
Brain Recordings in Patients Undergoing Deep Brain Stimulation (DBS) for Severe Obsessive-Compulsive Disorder (OCD)Obsessive-Compulsive DisorderNCT05915741Baylor College of Medicine8
招募中
不适用
Reinforcement Learning and Obsessive-compulsive Disorder: Exploring the Role of the Orbitofrontal CortexObsessive-Compulsive DisorderNCT06566781Fundacao Champalimaud230
Enrolling By Invitation
3 期
Ventral Capsulotomy for Intractable OCDObsessive-Compulsive DisorderNCT05659082Butler Hospital50
终止
2 期
N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive DisorderObsessive-Compulsive DisorderNCT00539513Yale University10
已完成
2 期
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive DisorderOcdObsessive-compulsive DisorderNCT00523718Yale University40