EUCTR2006-002411-27-BE进行中（未招募）不适用
Evaluation of the effect of escitalopram on cognitive and fine motor function in depressed elderly patients.
niversitair Psychiatrisch Centrum KU Leuven0 个研究点目标入组 40 人开始时间: 2006年9月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •In- and outpatients
- •Depressed patients, MDD, DSM IV-TR, single episode or recurrent
- •Elderly patients > 65 years
- •MMSE score > 24
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient suffers from any condition (e.g. Parkinson's disease, dementia, psychotic disorders, mental retardation, substance- or alcohol abuse, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR) that might effect cognitive or fine motor processes or compromise the study in another way.
- •The patient presents a personality disorder that might compromise the study.
- •The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included).
- •The patient uses the following disallowed recent or concomitant medication within the specified time periods:
- •-any antidepressant within the last week (5 weeks for fluoxetine, 2 weeks for fluvoxamine) prior to baseline.
- •-monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase A inhibitors (RIMAs) within 2 weeks prior to baseline.
- •-any drug used for augmentation of antidepressant action within the last week prior to baseline.
- •-any anxiolytics (including benzodiazepines) within the last week prior to baseline.
- •-any hypnotics within the last week prior to baseline, except zolpidem, zopiclone or zaleplon which can be prescribed episodically for insomnia.
- •-oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline.
- •-serotonergic medicinal products (for example, triptans, tryptophan, tramadol) within the last week prior to baseline.
- •-Lithium or valproate or other mood stabilizers within 2 weeks prior to baseline.
- •-Electroconvulsive therapy within 6 months prior to baseline.
- •-Herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba) within the last week prior to baseline.
- •-Any other drug with potential psychotropic effects within the last week prior to baseline.
- •-Any anticonvulsant drug within the last 2 weeks prior to baseline.
- •-Anticoagulants and/or medicinal products known to affect platelet function within the last 2 weeks prior to baseline.
- •-Potent inhibitors of CYP2C19 (for example, omeprazole) within the last 2 weeks prior to baseline.
- •-Cimetidine within the last week prior to baseline.
- •-Medicinal products that are predominantly metabolized by CYP2D6 if they have a narrow therapeutic index (for example, flecainide and propafenone) within the last 2 weeks prior to baseline.
- •-Any antihistaminics prior to baseline
- •-Any anitcholinergics prior to baseline.
- •The patient has demonstrated a lack of response to previous treatment with citalopram or escitalopram (including current episode).
- •The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or one of the ingredients.
- •The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
研究者
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