EUCTR2004-004984-32-SK进行中（未招募）1 期
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Major Depressive Disorder - N/A
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 348 人开始时间: 2005年3月7日最近更新:
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
- 348
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
- •Subjects must have the ability to comprehend the key components of the consent
- •Male or female outpatients aged 18-64, inclusive.
- •Primary diagnosis of MDE associated with MDD, single episode or recurrent,
- •according to DSM-IV-TR (296.2 or296.3), diagnosed through a comprehensive
- •psychiatric evaluation [in conjunction with the Mini International Neuropsychiatric
- •Interview (MINI), Clinician Rated Version 5.0], as assessed by a physician with
- •adequate training in psychiatry (e.g. Postgraduate qualification in psychiatry).
- •Subjects must, in the investigator’s opinion based on the subject’s history, have met
- •DSM-IV-TR criteria for their current MDE for at least 8 weeks prior to the
- •Screening Visit.
- •Subjects with a Carroll Depression Scale-Revised (CDS-R) self-assessment total
- •score of =24 at the Screen Visit and Baseline Visit.
- •Subjects must have a CGI- Severity of Illness score = 4 at the Baseline Visit.
- •Subjects with a history of peptic ulcer disease (PUD) with a known etiology must
- •provide documentation by a gastroenterologist of the etiology of the PUD and that
- •effective treatment was provided with full eradication of ulcers and symptoms. For
- •such subjects appropriate steps must also have been taken to minimize reoccurrence
- •risk (i.e. if PUD was nonsteroidal anti-inflammatory drug [NSAID] induced, the
- •subject should no longer be taking NSAID medications; if cause was H. pylori, the
- •subject should have been appropriately treated). For all subjects, regardless of
- •whether there is a positive history of PUD, sites are required to document their H.
- •pylori status at screening. Entry into the study is permitted for subjects who are
- •seropositive for H. pylori, but treatment is recommended, either before or after study
- •participation at the discretion of the Principal Investigator.
- •Women of childbearing potential must commit to consistent and correct use of an
- •acceptable method of birth control that must be recorded in the source
- •documentation at each visit; GSK acceptable contraceptive methods, when used
- •consistently and in accordance with both the product label and the instructions of a
- •physician, are as follows:
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
- •including any female who is post-menopausal. For purposes of this study,
- •postmenopausal is defined as one year without menses)
- •b. Child-bearing potential, has a negative serum pregnancy test result at screen and a
- •negative urine dipstick pregnancy test at baseline (prior to study drug
- •administration), and agrees to one of the following:
- •Male partner who is sterile prior to the female subject's entry into the study and
- •is the sole sexual partner for that female subject
- •Oral contraceptives (either combined or progestogen only) with double-barrier
- •method of contraception consisting of spermicide with either condom or
- •Double-barrier method of contraception consisting of spermicide with either
- •condom or diaphragm
- •IUD with a documented failure rate of less than 1% per year
- •Complete abstinence from intercourse for two weeks before exposure to the
- •investigational product, throughout the clinical trial, and for a period after the
- •trial to account for elimination of the drug (minimum of three days, equivalent
- •to five half lives)
- •c. If subjects indicate they will remain abstinent during the period described above,
- •they must agree to follow GSK guidelines for the consistent and correct use of an
- •acceptable method of birth control should the
排除标准
- •Subjects whose symptoms of the MDE are better accounted for by another diagnosis
- •Subjects with history of schizophrenia, schizoaffective disorders or bipolar
- •Subjects have positive urine test at screening for illegal drug use and/or a history of substance abuse or dependence
- •Subjects have a blood alcohol level of = 15 mg/dl (0.015%) at the Screening Visit
- •Subjects are currently receiving regularly scheduled psychotherapy, plan to initiate psychotherapy during the trial or have received regularly scheduled psychotherapy during the 12 weeks prior to the Screening Visit
- •Subjects have previously failed to respond to adequate courses of pharmacotherapy from two different classes of antidepressants or have failed to respond to an adequate course of paroxetine
- •Subjects who, in the investigator's judgement, pose a homicidal or serious suicidal
- •risk, have made a suicide attempt within the 6 months preceding screening or who
- •have ever been homicidal
- •Subjects who have received electroconvulsive therapy (ECT) or transcranial
- •magnetic stimulation (TMS) within the 6 months prior to the Screening Visit.
- •Subjects with any history of a seizure disorder
- •Subjects with an unstable medical disorder; or a disorder that would likely interfere
- •with the action, absorption, distribution, metabolism or excretion of GW679769; or
- •paroxetine, may pose a safety concern; or interfere with the accurate assessment of
- •safety or efficacy
- •Subjects with a history of myocardial infarction within 1 year prior to the
- •Screening Visit
- •Subjects have any screening laboratory value outside of the Sponsor-specified ranges at Screening Visit
- •Subjects have any laboratory abnormality that in the investigator's judgement is
- •considered to be clinically significant and not resolved by the Baseline Visit
- •Subjects who are not euthyroid based on lab results at the Screening Visit.
- •Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit
- •Subjects have any screening electrocardiography (ECG) parameter outside of the
- •Sponsor-specified ranges
- •Subjects have any ECG finding that in the investigator's judgement is considered to
- •be clinically significant and not resolved by the Baseline Visit
- •Subjects with active PUD and/or history of PUD of an unknown etiology
- •Subjects who will likely require the use of the following medications:
- •NSAIDs (unless administered concomitantly with an anti-secretory agent, i.e., proton-pump inhibitor or histamine-2 receptor antagonist and administered in the absence of concomitant aspirin therapy); or
- •concomitant use of aspirin and COX2 inhibitors.
- •Subjects found to have stool positive for occult blood
- •Subjects with known or suspected iron deficiency
- •Women who have a positive serum HCG pregnancy test at the Screening Visit, a
- •positive urine dipstick test at the Baseline (Randomization) Visit, or who are
- •lactating or planning to become pregnant within the 4 months following the Screen
- •Subjects who have taken other psychoactive drugs within two weeks prior to the
- •Baseline Visit or at any time during the Screening period:
- •all antidepressants including SSRI's
- •Monoamine Oxidase Inhibitors (MAOIs), benzodiazepines, other psychoactive
- •medications (including psychoactive herbal treatments, e.g., St. John's Wort,
- •Hypnotics, and all other sedatives (including sedating antihistamines if used for
- •their sedating and/or hypnotic properties)
- •Subjects who have taken other (non
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