Multicenter, Open-Label, Safety, Tolerability, and Pharmacokinetic Study to Evaluate Single Ascending Doses and Subsequent Short-Term Administration of Fixed Doses 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 59 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

阶段: 不适用
状态: 进行中（未招募）
发起方: Wyeth Research
入组人数: 59

研究概览入排标准研究者记录与标识符相似试验

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.Male or female outpatient.
•2.Ages greater than equal to (=) 7 or less than (<)18 years at baseline (study day -1).
•3.Meets Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD as assessed by the KIDDIE Schedule for Affective Disorders and Schizophrenia–Present and Lifetime Version (K-SADS-PL) and clinical interview.
•4.Children’s Depression Rating Scale—Revised (CDRS-R) score >40 at the screening and study day -1 (baseline) visits.
•5.Clinical Global Impressions Scale—Severity (CGI-S) score of =4 at the screening and study day -1 (baseline) visits.
•6.Depression of at least moderate severity with symptoms for at least 1 month before screening.
•7.Depression that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
•8.Able to participate as an inpatient for the first 3.5 days of the study.
•9.Able to swallow a placebo tablet or placebo tablets of size equal to the largest-sized DVS SR tablet studied in the subject’s respective age stratum.
•10.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.
•11.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: 59
•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

排除标准

•1.History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
•2.History or presence of any other medical condition that might confound the study or put the subject at greater risk during participation.
•3.Major acute illness within 90 days before the screening visit.
•4.History of suicide attempt or gesture in which the intent was suicide or serious self-harm.
•5.Acute suicidality to such a degree that precaution against suicide must be exercised.
•6.Screening or baseline (study day -1) score =5 on question 13 (Suicidal Ideation) of the CDRS-R.
•7.Screening or baseline (study day -1) score =3 on Item 3 (Suicide) of the HAM-D 17 .
•8.Screening or baseline (study day -1) determination of yes” on question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) for theSuicidal Ideation section of the Columbia Suicide-Severity Rating Scale (C-SSRS).
•9.Screening or baseline (study day -1) determination of yes” on question 5 (Active Suicidal Ideation with Specific Plan and Intent) for the Suicidal Ideation section.of the C-SSRS.
•10.Screening or baseline (study day -1) determination of yes” on the question of Actual Attempt for the Suicidal Behavior section of the C-SSRS
•11.First-degree relative who has completed suicide.
•12.Weight below the 10 th percentile for age based on the National Center for Health Statistics growth charts (2000 Centers for Disease Control and Prevention [CDC] growth charts).
•13.Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG), laboratory tests, or urine drug screen (UDS). The investigator and medical monitor will evaluate a positive UDS as to the potential impact and continued participation of the subject in the study.
•14.History of seizure disorder other than a single childhood febrile seizure.
•15.History or presence of Gilbert’s syndrome or a total bilirubin level of U =2.0 mmol/dL at screening.
•16.Known hypersensitivity to venlafaxine.
•17.History or presence of MDD with psychotic features.
•18.Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder.
•19.Current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
•20.Presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations.
•21.Presence of a mental disorder due to a general medical condition.
•22.History or presence of anorexia or bulimia.
•23.A first-degree relative with bipolar disorder (based on family history by the subject’s legally authorized representative [parent]).
•24.Sexually active male or female subjects who will not use medically accepted forms of contraception during study participation. Refer to the Screening section in the body of the protocol for a list of medically acceptable methods of contraception.
•25.Pregnancy, breastfee

研究者

发起方

Wyeth Research

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