ISRCTN45338259已完成未知
Antiglucocorticoid augmentation of antiDepressants in Depression: a double-blind randomised placebo-controlled parallel group trial
orthumberland, Tyne and Wear NHS Foundation Trust (UK)0 个研究点目标入组 190 人开始时间: 2009年12月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/02/2013:
- •1. Males and females aged 18-65 years
- •2. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) confirmed diagnosis of major depression
- •3. Severity - Patients must have a Hamilton Depression Rating Scale (HDRS17) score of 18 or greater, consistent with a moderate to severe episode. The stability of the patients' clinical state will also be confirmed with a 2 week baseline lead in period (week -2 to 0). A repeat HDRS17 score at time 0 is required to be 18 or greater.
- •4. Treatment refractoriness - assessed using the 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 6 weeks. For the trial to be considered as a failure it must have been considered by the clinical team to have been ineffective rather than the drug not taken or not tolerated. For inclusion, patients will have failed to have responded to at least their second trial of an antidepressant. This equates to a minimum score of 2 on MGH staging. The maximum MGH score for inclusion in the study will be 10.
- •5. At trial entry, patients must be taking monotherapy or combination antidepressant therapy that includes a serotonergic drug (a selective serotonin reuptake inhibitor [SSRI], a tertiary amine tricyclic, venlafaxine, duloxetine or mirtazepine). They must not be on noradrenergic antidepressant monotherapy eg. lofepramine, imipramine or reboxitene. At the point of randomisation, patients must have been on their current antidepressant medication, at the current dose, for a minimum of four weeks (protocol amendment approved 05/03/2012).
- •Previous inclusion criteria until 05/02/2013:
- •5. At trial entry, patients must be taking monotherapy or combination antidepressant therapy that includes a serotonergic drug (a selective serotonin reuptake inhibitor [SSRI], a tertiary amine tricyclic, venlafaxine, duloxetine or mirtazepine). (Added 16/06/2011: They must not be on noradrenergic antidepressant monotherapy eg. lofepramine, imipramine or reboxitene).
- •Previous inclusion criteria until 16/06/2011:
- •1. Males and females aged 18 - 70 years
- •3. Severity - Patients must have a Hamilton Depression Rating Scale (HDRS17) score of 18 or greater, consistent with a moderate to severe episode. The stability of the patients' clinical state will also be confirmed with a 2 week baseline lead in period (week 2 to 0). A repeat HDRS17 score at time 0 is required to be 18 or greater.
排除标准
- •Current exclusion criteria as of 05/02/2013:
- •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) (protocol amendment approved 15/08/20111)
- •2. Physical co-morbidity which would render the use of metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, cardiac failure, angina, myocardial infarction within the last 3 years, renal failure
- •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
- •Previous exclusion criteria until 05/02/2013:
- •1. Any other DSM IV Axis I disorder
- •2. Physical co-morbidity which would render the use of metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, cardiac failure, angina, myocardial infarction within the last 3 years, renal failure
- •3. Pregnancy - determined by history and if indicated, urine pregnancy test
- •4. Mothers who are breastfeeding (Added 21/06/2011)
- •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 (Added 21/06/2011)
研究者
相似试验
进行中（未招募）
1 期
Study to determine whether the addition of Metyrapone increases effects of anti-depressants in patients with depression.depressionEUCTR2009-015165-31-GBorthumberland, Tyne and Wear NHS Foundation Trust190
进行中（未招募）
1 期
A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860EUCTR2018-003096-35-ESCorcept Therapeutics Incorporated130
进行中（未招募）
1 期
A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 24.0Level: LLTClassification code 10011657Term: Cushings syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2018-003096-35-NLCorcept Therapeutics Incorporated162
进行中（未招募）
1 期
A study to assess whether relacorilant works and is safe to use in patients with Hypercortisolism due to Cortisol-Secreting Adrenal Adenomas or Hyperplasia; some patients will receive relacorilant whilst others receive a placebo.hypercortisolismMedDRA version: 22.1Level: LLTClassification code 10020611Term: HypercortisolismSystem Organ Class: 100000004860EUCTR2019-004956-12-ITCORCEPT THERAPEUTICS130
已完成
3 期
Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant10001353Cushing's syndromeNL-OMON54706Corcept Therapeutics Incorporated4