Deep Brain Stimulation in Treatment Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
研究概览
简要总结
This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.
详细描述
The first phase of the study will consist of implanting electrodes. Recruited patients will be random to 2 targets: (1) medial prefrontal cortex (mPFC); (2) nucleus accumbens (NAcc). Continuous stimulation will be applied until the patients stabilise clinically. This period is anticipated between 6 and 9 months.
After this stage, the next phase will consist of the crossover study. Those patients who respond to DBS will be randomly distributed in two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.
Weekly visits during first month after, and fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance.
Patients who complete the study and respond to treatment with DBS will be provided continuing with treatment, and keeping control visits to assess the long-term effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 55 years.
- •DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit.
- •Determined to be treatment-resistant as demonstrated by:
- •Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
- •Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
- •Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
- •ECT is contraindicated or have failed to produce a maintained response.
- •Persistence of positive symptoms defined as i) requiring a score of 4 (mild) or more on at least 2 of the next PANSS items: delusions, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
- •Current CGI score 6 or more
- •Stable antipsychotic treatment for last 2 months.
- •Women of childbearing age using medically approved contraceptive methods.
- •Adequate familiar or social support during all study procedures.
排除标准
- •MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
- •History of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed
- •Current suicidal ideation, plan or intent for self-harm during last 2 months.
- •Evidence of global cognitive impairment.
- •Current acute, serious or unstable illnesses.
- •History of substance abuse (other than tobacco or caffeine).
- •Comorbid axis I or II DSM IV-TR disorders.
- •Female patients who are pregnant or breastfeeding.
结局指标
主要结局
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
时间窗: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Scale to assess changes in schizophrenia' symptoms
次要结局
- Clinical Global Impression-Schizophrenia (CGI-SCH)(Changes from baseline score to 1-12 months scores)
- Global Functioning Scale (GFS)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Social Functioning Scale (SFS)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Personal and Social Performance (PSP)(Changes from baseline score to 1-12 months scores)
- Scale for the Assessment of Negative Symptoms (SANS)(Changes from baseline score to 1-12 months scores)
- Performance-Based Skills Assessment (UPSA)(Changes from baseline score to 12 months score)
- Psychotic Symptom Rating Scales (PSYRATS)(Changes from baseline score to 1-12 months scores)
- Calgary Depression Scale for Schizophrenia (CDSS)(Changes from baseline score to 1-12 months scores)
- Cerebral metabolism (PET scans)(Changes from baseline scan to 6 and 12 months scans)
- Neuropsychological Assessment(Changes from baseline score to 12 months score)
- Adverse events (AEs)(Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months))
- n-Back (fMRI scan)(Changes from baseline scan to 6 and 12 months scans)