EUCTR2004-000562-13-LV进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FLEXIBLE-DOSE STUDY OF DVS-233 SR AND VENLAFAXINE ER IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 360 人开始时间: 2004年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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
- •1. Outpatients.
- •2. Men and women 18 to 75 years of age, inclusive.
- •3. Women of child-bearing potential participating in the study must have a negative serum pregnancy test at screening and use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg condom plus diaphragm.
- •4. Subjects must have a primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features. If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present. (See Exclusion Criterion 6 for other psychiatric diagnoses that are not allowable.)
- •5. Depressive symptoms for at least 30 days before the screening visit.
- •6. Minimum screening and study day –1 (baseline) scores of 22 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).
- •7. Minimum screening and study day –1 (baseline) scores of 2 on item 1 (depressed mood) of the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).
- •8. Minimum screening and study day –1 (baseline) scores of 4 on Clinical Global Impressions-Severity scale (CGI-S).
- •9. Signed and dated informed consent before any screening procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment with DVS-233 SR at any time in the past.
- •2. Treatment with venlafaxine (immediate release [IR] or extended release [ER]), within 90 days of study day 1.
- •3. Known hypersensitivity to venlafaxine (IR or ER).
- •4. Significant risk of suicide based on clinical judgment. Common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
- •5. Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- •6. Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
- •7. A Covi Anxiety Scale total score greater than the Raskin Depression Scale total score at screening or at study day –1 (baseline). A Covi Anxiety score greater than 3 on any single item or a total score greater than 9 at screening or at study day -1 (baseline).
- •8. Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurological disorder.
- •9. History of a seizure disorder other than a single childhood febrile seizure.
- •10. History or presence of clinically important hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension).
- •11. History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or history of surgery known to interfere with the absorption or excretion of drugs.
- •12. History of neoplastic disorder (within 2 years), with the exception of basal or squamous cell carcinoma of the skin.
- •13. Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
- •14. Major acute illness during the 90 days before screening.
- •15. Myocardial infarction within 180 days before screening.
- •16. Clinically important abnormalities on screening physical examination, electrocardiogram (ECG), or laboratory tests. Clinically important abnormalities on screening urine drug screen (UDS), or a positive test result for tetrahydrocannabinol (THC), illicit opioids, or cocaine.
- •17. Use of prohibited treatments. Refer to the table that follows, Excluded Treatments sections 16.1 and 16.2 (Permitted Treatment and Prohibited Treatment) for treatments and associated time frames.
研究者
相似试验
进行中（未招募）
1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF A NOVEL CCR5 ANTAGONIST, UK-427,857, IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY VERSUS OPTIMIZED BACKGROUND THERAPY ALONE FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED, NON CCR5-TROPIC HIV-1 INFECTED SUBJECTSK-427,857 is an antagonist of the human chemokine receptor, and is intended to help prevent the development and progression of AIDS in individuals HIV-1 positive.EUCTR2004-001779-20-GBPfizer Limited186
进行中（未招募）
1 期
A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH)MedDRA version: 18.0Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersSpinal Muscular AtrophyEUCTR2014-002246-41-ESRoche Farma S.A., en nombre de F. Hoffmann-La Roche Ltd.64
进行中（未招募）
1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITISACTIVE PROLIFERATIVE LUPUS NEPHRITISMedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2022-001377-31-ESHorizon Therapeutics Ireland DAC210
进行中（未招募）
1 期
PROOF OF CONCEPT STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON AND MATCHING PLACEBO IN TRAVELERS WITH JET LAG DISORDERJet Lag Disorder (JLD)MedDRA version: 20.0 Level: PT Classification code 10040984 Term: Sleep disorder System Organ Class: 10037175 - Psychiatric disordersEUCTR2016-002213-21-GBVanda Pharmaceuticals Inc90
进行中（未招募）
不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 2 FIXED DOSES (50 mg, 100 mg) OF DESVENLAFAXINE SUSTAINED-RELEASE TABLETS IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDERMajor Depressive Disorder in outpatientsEUCTR2005-005463-28-LTWyeth Pharmaceuticals France, Wyeth Research Division480