EUCTR2005-003400-11-EE进行中（未招募）不适用
An Eight-week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group, Fixed-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.0 mg/day) or Paroxetine (30 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria
- •1. Male or female outpatients aged 18-64 years, inclusive.
- •2. Subject currently meets the diagnosis for MDE associated with MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3), diagnosed through a
- •comprehensive psychiatric evaluation (in conjunction with the Mini International Neuropsychiatric Interview (MINI), Clinician Rated Version 5.0 [Sheehan, 1998]),
- •as assessed by a physician with adequate training in psychiatry (e.g., Board
- •Certification in psychiatry in US; Certificate of Completion of Specialist training in
- •psychiatry in EU).
- •* Assessment by a physician with adequate training in psychiatry must include a face-to-face evaluation of the subject, but may be aided by subject evaluation conducted by a healthcare professional with a clinically relevant qualification (e.g., psychiatric nurse or psychologist) and a minimum of two years of documented experience assessing patients with MDD.
- •3. Subject must, in the investigators opinion based on clinical history, have met DSM-IV-TR criteria for their current MDE for at least 12 weeks but no greater than 24
- •4. Subjects with an IVRS IDS-SR total score =33 at the Screening and randomization
- •5. Subjects must have a CGI-S score of =4 at the Randomization Visit.
- •6. Subject must have the ability to comprehend the key components of the consent form and provide informed consent.
- •7. Subject must read and write at a level sufficient to complete study-related assessments.
- •8. A female subject is eligible to enter and participate in the study if she is of:
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal)
- •Post-menopausal females defined as being amenorrhoeic for greater than two years with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as post-menopausal should be advised to use contraception as outlined below.
- •Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy only when reproductive status has been confirmed by hormone level assessment.
- •b. Child-bearing potential, has a negative pregnancy test at Screening and randomization, and agrees to satisfy one of the following requirements:
- •Complete abstinence from intercourse from commencement of last normal menstrual period (2 weeks minimum) prior to administration of the first dose of study drug, throughout the Treatment Phase, and for a minimum of 8 weeks after completion or premature discontinuation from the study drug; or,
- •Established use of acceptable methods of contraception from commencement of last normal menstrual period (3 weeks minimum) prior to administration of the first dose of study medication, throughout the Treatment Phase, and for a minimum of 8 weeks after completion or premature discontinuation from the study drug. Acceptable methods of birth control are listed below:
- •Female sterilization (documented bilateral tubal ligation); or
- •Sterilization (vasectomy) of male partner prior to commencement of female subjects last normal menstrual period prior to administration of the first dose of study medi
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria
- •1. Subjects IVRS IDS-SR assessment increases or decreases by more than 25%
- •between the Screening (Week -1) and Randomization (Week 0) visits.
- •2. Subject has:
- •a. Symptoms of the presenting illness which are better accounted for by another
- •diagnosis*; or
- •b. A current DSM-IV-TR diagnosis of Panic Disorder; or
- •c. Symptoms of generalized anxiety or panic attacks that in the investigators
- •judgement could interfere with their ability to complete the trial; or
- •d. A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest nonresponsiveness to pharmacotherapy or non-compliance with the protocol; or
- •e. A current (or within six months prior to the Screening visit) diagnosis of
- •anorexia nervosa or bulimia; or
- •f. A DSM-IV-TR diagnosis of Bipolar Disorder, Schizophrenia, or other psychotic
- •disorder(s).
- •3. Subject has an unstable medical disorder; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK372475 or may
- •pose a safety concern, or interfere with the accurate assessment of safety or efficacy.
- •4. Subject has initiated psychotherapy within three months prior to the Screening
- •(Week 1) visit, or plans to initiate psychotherapy during the trial. Subjects who
- •present with their current MDD diagnosis despite longer-term psychotherapy (i.e.
- •greater than three months prior to the Screening visit) may be included.
- •5. Subject has received electroconvulsive therapy or transcranial magnetic stimulation within the six months prior to the Screening (Week 1) visit.
- •6. Subject has previously failed an adequate therapeutic course of pharmacotherapy for MDD (e.g., for =4 weeks) from two different classes of antidepressants or two
- •antidepressants within the same class.
- •7. Subject has a positive urine test at the Screening (Week 1) or Randomization (Week 0) visits for illicit drug use; a history of DSM diagnosed alcohol or substance abuse or dependence (other than nicotine) within the past 2 years or a blood alcohol level of =15mg/dl (0.015 %) at the Screening visit (Week 1). Note subjects must be told to avoid consumption of alcoholic beverages for at least eight hours prior to their Screening visit. The use of alcohol by subjects participating in the study is not recommended.
- •8. Subject, who, in the investigators judgement, poses a homicidal or serious suicidal risk, has had any previous suicide attempt, a family history of suicide attempts, or who has ever been homicidal.
- •9. Subject has any laboratory abnormality that in the investigators judgement is
- •considered to be clinically significant and could potentially affect subject safety or
- •study outcome.
- •10. Female subject is pregnant, lactating, or does not agree to use contraceptive
- •method(s) specified in the protocol to avoid pregnancy during the study.
- •11. Subject has a current or past history of seizure (except for febrile seizures in
- •childhood), or has a condition which, in the opinion of the investigator, predisposes
- •the subject to seizures.
- •12. Subject has a systolic blood pressure (SBP) >140mmHg or a diastolic blood pressure (DBP) =90mmHg at the Screening (Week 1) or Randomization (Week 0) visit.
- •13. Subject has taken:
- •a. any psychotropic drug within two weeks prior to the Randomization (Week 0)
- •visit, including all a
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