Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression

Cambridge Health Alliance0 个研究点目标入组 25 人开始时间: 2003年8月最近更新: 2017年4月18日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Cambridge Health Alliance
入组人数: 25
主要终点: Anxiety and Depressive Symptom severity

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.

详细描述

Study is 6 weeks long, with 7 clinical visits.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics

排除标准

•Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality

结局指标

主要结局

Anxiety and Depressive Symptom severity

次要结局

未报告次要终点

研究者

发起方

Cambridge Health Alliance

申办方类型

Other

责任方

Sponsor

相似试验

终止

2 期

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major DepressionMajor Depressive EpisodeBreast Cancer

NCT05063604Hospital Universitari de Bellvitge40

已完成

3 期

Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive DisorderMajor Depressive Disorder

NCT00863798Wyeth is now a wholly owned subsidiary of Pfizer682

已完成

3 期

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive DisorderMajor Depressive Disorder

NCT00798707Pfizer709

已完成

3 期

Experimental Medication For the Treatment of Generalized Anxiety DisorderAnxiety Disorder

NCT00097708Jazz Pharmaceuticals511

Unknown

2 期

A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major DepressionMajor Depression

NCT00289484The University of New South Wales52