D-cycloserine Enhancement of Exposure in Social Phobia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.
详细描述
Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.
Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.
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 (Participant, Investigator)
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
- •Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
- •Total score of greater than or equal to 60 on the LSAS
- •Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities
排除标准
- •Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
- •Eating disorder within the 6 months prior to study entry
- •History of organic brain syndrome, mental retardation, or other cognitive dysfunction
- •Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
- •Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
- •Suicidal thoughts
- •Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
- •Significant personality dysfunction
- •Serious medical illness or instability for which hospitalization may be likely within the next year
研究组 & 干预措施
CBT plus d-cycloserine
Participants will receive cognitive behavioral therapy plus D-cycloserine
干预措施: D-cycloserine (Drug)
CBT plus d-cycloserine
Participants will receive cognitive behavioral therapy plus D-cycloserine
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
CBT plus placebo
Participants will receive cognitive behavioral therapy plus pill placebo
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
CBT plus placebo
Participants will receive cognitive behavioral therapy plus pill placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Liebowitz Social Anxiety Scale (LSAS)
时间窗: Measured at Months 3
The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).
Social Phobic Disorders Severity and Change Form
时间窗: Measured at Months 3 (immediately after treatment)
Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).
次要结局
- Range of Impaired Functioning Tool(Measured at Months 3, 6, and 9 post-treatment)
- Social Phobia and Anxiety Inventory(Measured at Months 3, 6, and 9 post-treatment)
- Quality of Life Enjoyment and Satisfaction Questionnaire(Measured at Months 3, 6, and 9 post-treatment)
- Liebowitz Self-Rated Disability Scale(Measured at Months 3, 6, and 9 post-treatment)
研究者
Stefan G. Hofmann
Professor
Boston University Charles River Campus