Virtual Darkness as Additive Treatment in Mania- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Change in Young Mania Rating Scale (YMRS) score
研究概览
简要总结
In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group.
详细描述
Recent discoveries in neurophysiology has shown that "virtual darkness" is achievable by blocking blue wavelengths of light (Phelps, 2007). A newly discovered retinal photoreceptor called the Intrinsically photoresponsive retinal ganglion-cell (IpRGC) whose fibers directly synapses with the suprachiasmatic nucleus (SCN), responds only to a narrow band of wavelengths with highest sensitivity between 446 and 484 nm (Brainard et al., 2001; Berson 2007). Amber tinted goggles preserve normal nocturnal melatonin levels in light environments, which means that blocking of the blue wavelengths is perceived as virtual darkness to the SCN (Kayumov, 2005; Sasseville, 2006).
In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. The general feasibility of the method both in research and treatment will be evaluated. This is a multi-site study covering Helse Fonna Local Health Authority's catchment area wich serves a population of 120000 adults. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group. The study may contribute to develop a supplement to the current treatment in mania and may also generate new hypotheses about the underlying pathophysiological mechanisms in bipolar disorder.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT GROUPS
- •Inclusion Criteria:
- •Inpatients
- •Diagnosis of DSM IV-TR of Bipolar I or Bipolar II disorder with current manic episode as verified by the semistructured interview MINI plus
- •Ability to comply with the protocol
- •Willingness to participate in the study
- •Delayed written informed consent at discharge
排除标准
- •Inability to comply with the protocol
- •Severe retinal damage, cataract or corneal damage on both eyes
- •Daily use of NSAIDS
- •Daily use of betablockers
- •Daily use of calcium-antagonists
- •NON-BIPOLAR CONTROLS
- •Inclusion Criteria:
- •Written informed consent
- •Exclusion Criteria:
- •Working night shift
- •Diagnosed with bipolar disorder or single manic episode
- •Severe retinal damage, cataract or corneal damage on both eyes
- •Daily use of alcohol
- •Daily use of benzodiazepines
- •Daily use of NSAIDS
- •Daily use of betablockers
- •Daily use of calcium-antagonists
结局指标
主要结局
Change in Young Mania Rating Scale (YMRS) score
时间窗: Change from baseline in YMRS score after 7 days
The YMRS-score is assessed daily at 12 a.m. for 7 days
次要结局
- Change in motor activity measured by use of actigraphy, Actiwatch Spectrum device(Change in motor activity over 7 days ( patients) or 14 days ( non-bipolar controls) .)
研究者
Tone Elise Gjoetterud Henriksen
Chief Consultant
Helse Fonna
