Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- SIGH-ADS Depression Score
研究概览
简要总结
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
详细描述
Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65 years
- •DSM-IV Criteria BD I or II depressive episode,
- •SIGH-ADS >20; duration >2 weeks.
- •Stable dose antidepressant drug >8 weeks with concurrent antimanic drug
- •Controlled thyroid disease
- •Subjects with preexisting eye diseases will be included.
- •Able to provide informed consent
- •Stable minimum dose antimanic drug >4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
- •Stable unchanged psychotherapy for >16weeks
排除标准
- •The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
- •Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
- •Acute psychosis (DSM-IV Criteria)
- •Rapid cycling in the past 1 year
- •Obsessive compulsive disorder
- •Alcohol or substance abuse or dependence in the past 6 months.
- •Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 >2)
- •Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
结局指标
主要结局
SIGH-ADS Depression Score
时间窗: 6 weeks
The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.
次要结局
- Global Assessment of Functioning (GAF)(6-weeks)
研究者
Dorothy Sit
Associate Professor of Psychiatry and Behavioral Sciences
Northwestern University