NCT00452595已完成3 期
A 12-Month Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Outpatients With Major Depressive Disorder
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 主要终点
- HAM-D17
研究概览
简要总结
To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during open-label treatment of outpatients with major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients.
- •Men and women aged 18 to 75 years.
- •Women of childbearing potential must have a negative serum pregnancy test result at screening. Sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.
- •Subjects must have a primary diagnosis of 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, on study day
- •If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present. (See Exclusion Criterion 6 for psychiatric diagnoses that are not allowable.)
- •Depressive symptoms for at least 30 days before the screening visit.
- •Subjects who have symptoms of depression judged by the investigator to require long-term treatment (i.e., 6 months or longer) with an antidepressant drug.
- •Other inclusion applies.
排除标准
- •Treatment with DVS-233 SR at any time in the past.
- •Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day
- •Known hypersensitivity to venlafaxine (IR or ER).
- •Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- •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).
- •Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
- •History of a seizure disorder other than a single childhood febrile seizure.
- •Other exclusion applies.
结局指标
主要结局
HAM-D17
次要结局
- MADRS, CGI-S, CGI-I, Covi Anxiety Scale, SDS, VAS-PI, and WHO-5
研究者
相似试验
已完成
3 期
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive DisorderMajor Depressive DisorderNCT01309542Pfizer1,403
已完成
2 期
Study Evaluating DVS SR in Patients With Fibromyalgia SyndromeFibromyalgiaNCT00424892Wyeth is now a wholly owned subsidiary of Pfizer600
已完成
3 期
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)Major Depressive DisorderNCT00831415Pfizer304
已完成
2 期
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive DisorderDepressive Disorder, Major Depressive DisorderNCT00669110Wyeth is now a wholly owned subsidiary of Pfizer40
已完成
3 期
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDDMajor Depressive DisorderNCT01371721Pfizer269