A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Sheehan-Suicidality Tracking Scale (S-STS)
研究概览
简要总结
The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
- •Ability to speak, read and understand the English Language and provide written informed consent
排除标准
- •Current, unstable and significant medical condition or illness
- •History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
- •Pregnant or lactating females
- •Abnormal clinical laboratory test results
- •Intolerance or hypersensitivity to SSRIs or lithium
- •History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia
- •Certain mediations my not be used prior or during the study
研究组 & 干预措施
sugar pill
干预措施: Placebo (Drug)
sugar pill
干预措施: Citalopram (Drug)
Lithium
干预措施: Lithium Carbonate (Drug)
Lithium
干预措施: Citalopram (Drug)
结局指标
主要结局
Sheehan-Suicidality Tracking Scale (S-STS)
时间窗: 4 weeks; from Baseline to Week 4
The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4.
次要结局
- Beck Hopelessness Scale (BHS)(4 weeks)
- Beck Scale for Suicide Ideation (BSS)(4 weeks)