EUCTR2009-015165-31-GB进行中（未招募）1 期
Antiglucocorticoid augmentation of antiDepressants in Depression: a double-blind, randomised, placebo-controlled, parallel-group trial - Antiglucocorticoid augmentation of antiDepressants in Depression (ADD Study)
orthumberland, Tyne and Wear NHS Foundation Trust0 个研究点目标入组 190 人开始时间: 2010年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patient should be suffering from a DSM-IV major depressive episode, as described below: 1. Severity of depression. - Hamilton Depression Rating Scale (HDRS17) score of 18, or greater (rated using the GRID-HAMD), consistent with a moderate to severe episode. The stability of the clinical state will also be confirmed with a two week baseline lead in period (week -2 to 0). - A repeat HDRS17 score at time 0 is required to be 18 or greater. 2. Treatment refractoriness. - Assessed using Massachusetts General Hospital (MGH) staging method. This defines minimum effective doses of all currently available antidepressants and an adequate trial as being for at least six weeks. For the trial to be considered a failure, it must have been considered by the clinical team to have been ineffective rather than the drug not taken or not tolerated. - Failure to respond to at least the second trial of an antidepressant. (This equates to a minimum score of two on MGH staging. The maximum MGH score for inclusion in the study will be 10. A study in the UK has shown mean MGH scores in primary care patients of less than one, in secondary care mental health settings of around five and eleven in a population of patients referred to a tertiary centre (Dr D Christmas, Dundee, Personal Communication). 3. Current anti-depressant treatment - At trial entry, patients must be taking monotherapy or combination antidepressant therapy that includes a serotonergic drug (an SSRI, a tertiary amine tricyclic, venlafaxine, duloxetine or mirtazepine). They must not be on noradrenergic anti-depressant monotherapy (eg. with lofepramine, imipramine or reboxetine). At the point of randomisation, patients must have been on their current anti-depressant medication, at the current dose, for a minimum of four weeks. 4. Aged 18-65 - Patients will be included who are aged 18-65. For the mechanistic substudies the upper age limit is 60. For the healthy controls (inclusion criteria): 1. Currently psychiatrically well confirmed through SCID interview. 2. HDRS17 score of five or less 3. No current psychotropic medication 4. No past history of psychiatric illness as revealed by SCID interview, or requiring any treatment (formal psychotherapy or psychotropic medication) 5. No first degree family history of psychiatric illness 6. Aged 18-60
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Any other DSM IV Axis I disorder, other than an anxiety disorder unless the depressive episode is considered to be secondary to the anxiety disorder, confirmed using the Structured Clinical Interview for DSM (SCID). 2. Physical co-morbidity which would render the use of Metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, current, severe cardiac failure, current, severe or frequent angina, current renal failure or myocardial infarction within the last year. 3. Pregnancy - determined by history and, if indicated, urine pregnancy test. 4. Mothers who are breastfeeding. 5. Use of concomitant medication that would interfere in a pharmacodynamic or pharmacokinetic manner with Metyrapone. 6. Dependence on alcohol or other drug in the past 12 months, and/or current harmful use of alcohol or other drug. 7. Recently having taken part in another research study that could interfere with the results of this one. For the healthy controls: 1. Any DSM IV Axis I disorder. 2. Any physical ill health which would render the use of Metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, current, severe cardiac failure, current, severe or frequent angina, current renal failure or myocardial infarction within the last year. 3. Pregnancy - determined by history and if indicated, urine pregnancy test. 4. Mothers who are breastfeeding. 5. Use of any medication that would interfere in a pharmacodynamic or pharmacokinetic manner with Metyrapone. 6. Dependence on alcohol or other drug in the past 12 months and/or current harmful use of alcohol or other drug.
研究者
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Antiglucocorticoid augmentation of antiDepressants in Depression: the ADD studyMajor depressionMental and Behavioural DisordersDepressionISRCTN45338259orthumberland, Tyne and Wear NHS Foundation Trust (UK)190
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