ACTRN12613000256774已完成4 期
The objective of this European multicentre study was to evaluate escitalopram efficacy and tolerability in a population which has been shown to have Treatment Resistant Depression (TRD) in a prospective open treatment phase with venlafaxine over a 6 week period at an adequate dose after non response to previous antidepressants
undbeck0 个研究点目标入组 417 人开始时间: 2013年3月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 417
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •To be included in the 6 week prospective treatment with venlafaxine each patient had to: 1. be able to read and understand the patient information sheet; 2. have signed the informed consent form; 3. be an in- or outpatient, male or female, of at least 18 years of age; 4. have a Current Major Depressive Episode, assessed with the Mini International Neuropsychiatric Interview (MINI), moderate or severe, according to DSM-IV-TR criteria (classification codes: 296.2x or 296.3x); 5. have been treated for the Current Episode with any antidepressant (AD1) (other than escitalopram or venlafaxine) prescribed continuously at its optimal dose (Annex 1) for at least 4 weeks (criterion verified at screening) – if at inclusion the patient was not during AD1 period of any antidepressant, this period without antidepressant should not have exceeded 4 weeks); 6. be a non-responder to this previous treatment (AD1) (Montgomery Asberg Depression Rating Scale (MADRS) improvement <50%); 7. have a total score equal or above 22 on the MADRS.
排除标准
- •To be excluded from the study each patient had to: 1. have previously participated in this study; 2. be a non responder to a combination of 2 antidepressants (at least 2 weeks of treatment with an adequate dose for each of the 2 drugs) and/or to an augmentation therapy (at least 2 weeks with a potentiating agent at any dose) at the time of screening; 3. have a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or venlafaxine; 4. have one or more of the following conditions: a. any Current Psychiatric Disorder established as the principal diagnosis other than Major Depressive Disorder as defined in the DSM-IV-TR (assessed with the MINI); b. any Substance Disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR; c. any severe Personality Disorder according to investigator clinical judgement that might compromise the study; 5. have received one or more of the following disallowed treatments: a. oral antipsychotic drugs had to have been stopped at least 2 weeks before inclusion; the patient could be included if the antipsychotic medication had been taken at infra-therapeutic dose (lower than the recommended dose as indicated in the notice of the product); patients were excluded if they had received a depot antipsychotic preparation within the past 6 months; b. ECT within the past 6 months; c. lithium, carbamazepine, lamotrigine, valproate or valpromide at therapeutic dose and for more than 2 weeks within the past month; d. benzodiazepines: more than 25 mg/day of diazepam or equivalent within the last week for chronic users of benzodiazepines (more than 3 months on treatment) and more than 10 mg/day of diazepam or equivalent for non chronic users (less than 3 months); e. more than 20 mg/day of zolpidem, 15 mg/day of zopiclone or 20 mg/day of zaleplon within the last week; f. any non-benzodiazepine anxiolytic within the last week; g. any serotonin agonist (e.g., triptans) within the last week; h. any other drug with potential psychotropic effects within the last week; i. any investigational product within 3 months prior to screening; j. escitalopram or venlafaxine at adequate dose and duration during the Current Episode; k. formal psychotherapy started in the month preceding inclusion; 6. have a previous history of convulsive disorder other than a single childhood febrile seizure; 7. present evidence of urinary retention or glaucoma; 8. have a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance; 9. have, in the opinion of the investigator (based on physical examination, medical history and vital signs), comorbid conditions(s) that would render inclusion in the study unsafe; 10. take medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy; 11. in female patients, be pregnant or breastfeed at inclusion as well as during the study; 12. be, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any reason.
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