DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
- 试验地点
- 16
- 主要终点
- STAI YB
研究概览
简要总结
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.
There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women older than 18 years-old;
- •Suffering from a Mood Depressive Episode ( according to DSM IV criteria), and-or Mood Depressive recurrent depression (unipolar or bipolar) (<at stage 3 of Thase and Rush). Treatment resistance will be assessed using Thase an Rush Classification and measured with Maudsley Staging Method (Fekadu et al., 2009);
- •MADRS score 15;
- •Capacity for the patient to receive information on protocol;
- •Patient who gave their consent to the protocol.
排除标准
- •Contra-indication to MRI
- •Patients under social protection or hospitalized without their consent
- •Patients suffering from a psychiatric comorbidity such as: schizophrenia, schizo-affective disorder, personality disorder, actual addiction, anorexia-bulimia, obsessive-compulsive disorder;
- •Patients suffering from severe intercurrent disease with health prognosis engaged;
- •Patients suffering from neurological comorbidity such as: any neurodegenerative disorder (Alzheimer disease, Parkinson disease, Lewy's body disease, multiple sclerosis), any intracranial expansive process.
- •Patients with an history of severe cranial injury (with coma);
- •Patients with abnormal cerebral MRI.
研究组 & 干预措施
depressiv people
干预措施: inflammatory, neuropsychological and neuroimaging assessment (Other)
结局指标
主要结局
STAI YB
时间窗: at baseline.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
MADRS Scale
时间窗: at 36 months
Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
次要结局
- STAI(at 6, 12, 24, 36 months)
- SHAPS(at 6, 12, 24, 36 months)
- CGI(at 6, 12, 24, 36 months)
- Trail Making Test(TMT) Part A and B(at 6, 12, 24, 36 months)
- Verbal fluences(at 6, 12, 24, 36 months)
- CPT III(at 6, 12, 24, 36 months)
- IRM(At baseline and at 36 months)
- MADRS Scale(at 6, 12, 24 months)
- MSM(at 6, 12, 24, 36 months)
- Mattis Scale(at 6, 12, 24, 36 months)
- MCST(at 6, 12, 24, 36 months)
- AES(at 6, 12, 24, 36 months)
- ERD(at 6, 12, 24, 36 months)
- YMRS(at 6, 12, 24, 36 months)
- Edinburgh Laterality Test(at 6, 12, 24, 36 months)
- HAMA(at 6, 12, 24, 36 months)
- Empan(at 6, 12, 24, 36 months)
- Stroop Test(at 6, 12, 24, 36 months)
- MADRS(at 6, 12, 24, 36 months)
- Beck(at 6, 12, 24, 36 months)