Pharmacotherapy in Depression With Panic Spectrum
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Somatic Symptoms Scale (SSC)
研究概览
简要总结
This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.
详细描述
Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.
Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18-60;
- •Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
- •Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
- •Physically healthy,
- •Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;
排除标准
- •Females who are pregnant or breast-feeding;
- •History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
- •History of hypersensitivity to or current use of sertraline;
- •Unstable or untreated medical conditions,
- •Participants who do not wish to discontinue current, ineffective antidepressant treatment;
- •Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
- •Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.
研究组 & 干预措施
Sertaline high dose titration
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline high dose titration) are consistent with recommended FDA guidelines.
干预措施: sertraline hydrochloride (Drug)
Sertaline low dose titration
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline low dose titration) are consistent with recommended FDA guidelines.
干预措施: sertraline hydrochloride (Drug)
结局指标
主要结局
Somatic Symptoms Scale (SSC)
时间窗: 1 week
Scale to evaluate somatic and panic like symptoms
次要结局
- Global Assessment of Functioning (GAF)(past week)
- Hamilton Rating Scale For Depression- 25 item (HRSD 25)(1 week)
研究者
Andrea Fagiolini
Associate Professor
University of Pittsburgh