Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
研究概览
简要总结
Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders:
- •panic disorder with agoraphobia
- •obsessive compulsive disorder
- •major depressive disorder
- •generalized anxiety disorder
- •Score on LSAS > 50
- •Score on MADRS < 25
排除标准
- •Any other primary AXIS-I diagnosis
- •Criteria for alcohol/substance abuse/dependence
- •History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder
- •A comorbid Axis II cluster A personality disorder
- •Current increased risk of concomitant suicide
- •Allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline
- •Participation in any clinical trial 30 days prior to entering the study
- •Unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks
- •Hx of seizures
- •Thyroid problems
研究组 & 干预措施
1
Sertraline
干预措施: Sertraline (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
时间窗: 16 weeks
Clinical Global Impression - Improvement ≤ 2
时间窗: 16 weeks
次要结局
- Social Phobia Scale(16 weeks)
- Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire(16 weeks)
- Sheehan Disability Scale(16 weeks)
- Brief Social Phobia Scale(16 weeks)
- Penn State Worry Questionnaire(16 weeks)
- Panic and Agoraphobia Scale(16 weeks)
- Davidson Trauma Scale(16 weeks)
- Social Anxiety Spectrum Self-Report (SHY-SR)(16 weeks)
- Yale-Brown Obsessive Compulsive Scale(16 weeks)
- Montgomery-Asberg Depression Rating Scale (MADRS)(16 weeks)