Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)
研究概览
简要总结
This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.
详细描述
Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an "open label" study so all participants know what the treatment is.
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
- •current major depressive episode (MDD, BP-I or BP-II)
- •if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
- •If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
- •physically healthy
- •not taking current antidepressants(antidepressants deemed effective will not be discontinued
排除标准
- •medically unstable condition
- •past intolerance of lithium (bipolar only)
- •history of (or current) psychosis or epilepsy
- •current (past six months) drug or alcohol abuse/dependence
- •contraindication to lithium (bipolar only)
- •significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
- •currently taking effective antidepressant
- •cognitive dysfunction
- •Parkinson's Disease
- •Thyroid Stimulating Hormone > 5 milli International Units/Liter
- •left ventricular hypertrophy
- •symptomatic mitral valve prolapse
- •abnormal creatinine
研究组 & 干预措施
Wake Therapy + light box +/- lithium
- Bipolar patients must take lithium; others do not take lithium
- all patients are hospitalized for a week during which they do not sleep on alternating nights
- for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
干预措施: Wake Therapy (Behavioral)
Wake Therapy + light box +/- lithium
- Bipolar patients must take lithium; others do not take lithium
- all patients are hospitalized for a week during which they do not sleep on alternating nights
- for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
干预措施: light box (Device)
Wake Therapy + light box +/- lithium
- Bipolar patients must take lithium; others do not take lithium
- all patients are hospitalized for a week during which they do not sleep on alternating nights
- for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
干预措施: Lithium (Drug)
结局指标
主要结局
Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)
时间窗: up to 6 weeks
This is a structured interview to obtain 17 Hamilton Depression Rating Scale ratings, with 8 additional items added to measure reverse vegetative features common in bipolar depression and depression with atypical features. There are total 25 items, score ranges from 0 to 90. Higher score means worse depression.
次要结局
- Morningness-Eveningness Questionnaire (MEQ),(up to 6 weeks)
- Symptom Check List (SCL-90)(up to 6 weeks)
- Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)(up to 6 weeks)
- Hypomania Interview Guide, Current Assessment Version (HIGH-C)(up to 6 weeks)
- Clinical Global Improvement (CGI)(up to 6 weeks)
研究者
David J. Hellerstein
Principal Investigator
New York State Psychiatric Institute