6-Month, Multicenter, Open-Label, Flexible-Dose Study To Evaluate Safety, Efficacy, And Tolerability Of Desvenlafaxine Succinate Sustained-Release Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

Wyeth Research0 个研究点目标入组 40 人开始时间: 2015年4月3日最近更新: 2015年4月13日

适应症

试验速览

暂无简介。

•1.Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000-US, and who, in the opinion of the investigator, would benefit from long-term treatment.
•2.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
•3.For sexually active subjects, the signed and dated informed consent and assent forms should reflect an awareness of the stipulations concerning the use of contraception. For sexually active subjects, condoms should be used in addition to other contraceptive methods for the duration of study participation and for 15 days after the last dose of test article in order to provide protection against sexually transmitted diseases and to provide additional protection against accidental pregnancy. It is important that subjects not become pregnant or impregnate others while they are in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of study 3151A6-2000-US. If an exception for an underlying illness was granted for entry into 3151A6-2000-US and if the condition remains stable (ie, no exacerbation), then the subject may enter this 6-month extension study provided that the exception is discussed with and granted by the medical monitor before study entry.
•2.Unresolved clinically significant adverse events or serious adverse events in study 3151A6-2000-US.
•3.Meets any of the exclusion criteria listed for study 3151A6-2000-US.
•4.Poor compliance with protocol 3151A6-2000-US, as assessed by the investigator and the medical monitor.

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