Short-term Versus Long-term Treatment in Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Anxiety
研究概览
简要总结
This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.
详细描述
Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.
Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GAD diagnosis by structured interview
- •Hamilton Anxiety Scale score of 18 or MORE
- •Clinical Global Impressions Severity Scale score of at least 4
- •Hamilton Depression Scale score of 18 or less
- •Hamilton Depression Scale suicide item score less than 2
- •Use of an effective form of contraception throughout the study
排除标准
- •Hypersensitivity to venlafaxine XR
- •History of seizures
- •Episode of major depressive disorder in the previous 6 months
- •History of any psychotic illness, bipolar disorder, or dementia
- •Substance abuse and dependence during the past 6 months
- •Other anxiety disorders with the exception of social phobia as long as GAD is primary
- •Regular use of anxiolytics or antidepressants within 7 days of study onset
- •Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
- •Use of other psychotropic medication besides benzodiazepines during the study
研究组 & 干预措施
Open-Label Group
6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d
干预措施: Venlafaxine XR (Drug)
Double-Blind Drug Group
6-month randomized, double-blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 6 - 12 of the study
干预措施: Venlafaxine XR (Drug)
Double-Blind Placebo Group
6-month randomized, double blind phase of placebo occurring between months 6 - 12 of the study
干预措施: Placebo (Drug)
Double-Blind Drug-After-Drug Group
6-month randomized, double blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 13 - 19 of the study
干预措施: Venlafaxine XR (Drug)
Double-Blind Placebo-After-Drug Group
6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
干预措施: Placebo (Drug)
Double-Blind Placebo-After-Placebo Group
6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Rating Scale for Anxiety
时间窗: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)
Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
次要结局
- Clinical Global Impressions, Severity of Illness(Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse))
研究者
Karl Rickels
Professor of Psychiatry
University of Pennsylvania