Cerebral Functional Modifications After Low Frequency Repetitive Transcranial Magnetic Stimulation in Refractory Depression. Assessment With 18F-FDG-PET Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Variation of the regional cerebral glucose consumption between the two PET-TDM
研究概览
简要总结
Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations
详细描述
In France, lifetime prevalence of depression is 21 %, with major consequences: handicap, loss of productivity, reduction in quality of life, increased mortality. The efficient and long-lasting care of depression is consequently a priority of public health.
Despite well-conducted conventional therapeutic strategies, it is estimated that about 30 % of the depressed patients do not respond at all to an antidepressant, that 30 % will present a partial response, and that 40 % only patients will have a complete remission.
Non-pharmacological alternative treatments have been promoted, particularly with repetitive transcranial magnetic stimulation (rTMS). A recent meta-analysis with 29 randomized controlled trials versus placebo reports a 29.3 % response rate and a 18.6 % remission rate after active stimulation vs respectively, 10.4 % and 5 % after placebo stimulation.
However, predictive biomarkers of response are unknown, and cerebral metabolism may be a good candidate. It is admitted that the depressive state is correlated with specific modifications of glucose metabolism in circuits which are involved in the neurobiology of depression. The amplitude of these changes may correlate with clinical severity or may differ with treatment type, and cerebral metabolic changes might be an additional guide to treatment. Finally, the therapeutic effect might normalize cerebral functional activity and this might be an early correlate of clinical response. However the studies using functional imaging in a therapeutic approach or in the understanding of the physiopathology of the depression are not usable in a clinical practice of routine.
The investigators suggest using a well-known analysis software (Scenium software, Siemens GmbH) who allows an automated analysis by the distribution of the cerebral metabolism by means of the F18-FDG TEP-TDM and a quantitative measure, expressed in regional consumption of glucose expressed by g / 100 g / min for every 18F-FDG TEP-TDM and for every region of interest. Image registering by the camera, remote of the injection of the tracer, lasts less than 10 minutes.The software also allows to compare the data acquired for a patient with a standardized database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject from 40 to 65 years old
- •Characterized current depressive Episode, unipolar, without psychotic characteristic (according to DSM IV-TR)
- •Presenting to the inclusion a score upper or equal to 20 on the scale HDRS-17
- •Absence of answer or partial clinical answer to more than two antidepressant treatments of different therapeutic classes to effective posology on a duration of at least 6 weeks
- •Patient affiliated to French social security
- •Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
排除标准
- •Failure in a previous low-frequency rTMS cure (at least 15 sessions)
- •Failure in a cure of bilateral ECT (at least 8 sessions) or unilateral (at least 10 sessions)
- •Mental disorder owed to a general medical affection ( DSM-IV)
- •Presence of a neurodegenerative pathology in the inclusion estimated on the clinical examination, the intellectual MRI, the TEP / TDM at the 18F-FDG and the neuropsychological profile in the inclusion
- •Severe or not stabilized somatic Disease
- •chronic depression evolving for more than 3 years
- •Not answer in more of therapeutic antidepressive five well (documented) conducts
- •Presence of contraindication the SMTr, of which epileptic disease
- •Schizophrenic Disorder
- •Addicting Disorder with current dependence (alcohol, cannabis, benzodiazepin)
- •Bipolar disorder (I, II)
- •Disorder of personality to cluster A and B co-morbid
- •Pregnant Woman (dosage of urinary Beta-HCG)
- •Vulnerable Person: major under guardianship or guardianship, minor
- •Mental Deficiency of the subject making its participation on approval impossible
- •Participation in another clinical trial
结局指标
主要结局
Variation of the regional cerebral glucose consumption between the two PET-TDM
时间窗: at week 6
Variation of the regional cerebral glucose consumption between the two PET-TDM (realized at inclusion and at Week 6)
次要结局
- Comparison of local glucose use between responder and non-responder patients(at week 6)