EUCTR2011-005200-15-FI进行中（未招募）不适用
A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients with Major Depressive Disorder.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 326
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
- •Demographic
- •Men and women between 21 and < 65 years of age
- •Patient is a male or female not of reproductive potential or female of reproductive potential agreeing to use 2 regionally accepted effective non-hormonal forms of contraception (or abstinent)
- •Patient's regular bedtime is between 9 PM (21:00) and 1 AM (01:00).
- •Patient’s caffeine consumption does not exceed = 5 standard 6 oz cups/day and patient is willing to continue this behavior throughout the study.
- •Patient’s alcohol consumption does not exceed 2 drinks/day, at least 3 hr before bedtime, and the patient is willing to continue this behavior throughout the study.
- •Patient is able to read and operate an electronic diary.
- •Patient is at least 75% compliant with completion of the electronic diary (eDiary) during the Screening Period. Patient must complete the eDiary entries for a minimum of 4 days.
- •Primary diagnosis of recurrent MDD, without psychotic features (DSM-IV-TR).
- •Duration of the current depressive episode must be at least 2 months but no more that 1 year at screening.
- •At screening, patient is has been on an adequate trial of SSRI or SNRI (See Protocol, Table 2-1) for the current depressive episode. For this protocol, an adequate trial of an SSRI/SNRI is defined as at least 5 weeks of treatment with one of the antidepressants listed below, at an adequate dose for at least 3 weeks (see protocol Table 2-1). Adequacy of the trial, based on duration of treatment and dose must be confirmed by the Investigator with the patient’s primary treating clinician.
- •Patient can be maintained on current dose of SSRI-SNRI throughout study.
- •At Visits 1 and 2, the patient meets HAM-D entry criterion, as specified by Sponsor (blinded) and confirmed by IVRS.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 326
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Demographic
- •Patient has history of transmeridian travel (across > 3 time zones) or shift work (permanent night shift or rotating day/night shift work) within past 2 wks or will have to travel (across > 3 time zones) at any time during the study.
- •Patient’s current depressive episode is his/her first depressive episode.
- •Patient has a current primary diagnosis (ie, a diagnosis designated by the investigator as the primary source of current distress and functional impairment) of an Axis I disorder other than MDD.
- •Patient has a lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, as determined by the investigator. Note that a history of psychotic features in the context of a previous depressive episode is permitted; however psychotic features associated with the current episode are exclusionary.
- •Patient has a known or suspected personality dysfunction that could, in the investigator's opinion, interfere with trial participation or efficacy evaluation. A patient with known antisocial or borderline personality disorder should be excluded.
- •Patient has a diagnosis of mental retardation, a history of traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease or another form of dementia, or any chronic organic disease of the central nervous system.
- •Patient is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., MADRS item 10 > 3 and/or Type 4 or 5 on the C-SSRS) in the past 1 month or suicidal behavior in the past 6 months.
- •Patient currently (within the past year) meets criteria for alcohol or other substance abuse or dependence (excluding nicotine), posttraumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), or eating disorder.
- •Patient has a positive screening urine drug screen (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.).
- •Medications and Treatments
- •Patient has an inadequate response to up to 3 antidepressant trials for current episode, in the investigator's opinion.
- •Patient uses anxiolytic or sedative-hypnotic agents chronically (=4 times/wk).
- •Patient is taking a prohibited medication (see protocol Table 2-2) within the specified washout period and during the study.
- •Patient has a history of hypersensitivity or idiosyncratic reaction to more than two pharmacologic classes of drugs, including prescriptions and over-the-counter medications.
- •If female: pregnant, breastfeeding, or expecting to conceive within duration of study
- •Patient has a Body Mass Index > 40 kg/m2.
- •Patient has a history or current evidence of any clinically significant disease that according to the investigator might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.
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