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Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker (LightEyeBD)

2018年3月27日 更新者：Dorothy Sit、Northwestern University
Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and limited, and clinical decision making is less refined. Currently, the investigators are investigating the effects of midday bright light therapy for the treatment of bipolar depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a possible biological mechanism which might explain response to light treatment in depressed bipolar patients.

研究概览

地位

完全的

条件

详细说明

The study goal is to understand how the response to light therapy relates to changes in vision, brain function and improvement in bipolar symptoms. The aims are to investigate mood levels plus the eye and brain responses to visual contrast stimuli in healthy comparators (HC) and bipolar depressed patients.

Study Design and Methods. Overview. The investigators plan to enroll 18-50 year old adults with BD Type I or II and a current episode of major depression on stable-dosed antimanic drugs, and age and sex-matched HC - without mental disorders. Depressed patients with BD will be assigned randomly to receive active light therapy vs inactive comparator for 6 weeks. The investigators will examine responses to contrast stimuli from measures of visual evoked potentials and electro-retinography in HC and depressed bipolar patients before and after 6-weeks of daily midday light therapy. The investigators will assess repeated measures of mood symptom levels, attention and circadian rhythms.

研究类型

观察性的

注册 (预期的)

91

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • Western Psychiatric Institute and Clinic

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

community patient sample

描述

Inclusion Criteria:

  • Ages 18-50 years.
  • DSM-IV BD Type I or II, current major depressive episode
  • Stable-dosed antidepressant drug for 4 weeks or more only with concurrent antimanic drug.
  • Controlled thyroid disease.
  • Subjects with preexisting eye diseases will be included specific exceptions are described in the Exclusion Criteria.
  • Able to provide informed consent.
  • Stable minimum dose of antimanic drug for 4weeks or more.
  • Stable unchanged psychotherapy for 16 weeks or more.
  • Permitted drugs for sleep at low doses.

Exclusion Criteria:

  • Certain specific eye diseases (retinal disease, untreated cataracts or macular degeneration)
  • Photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
  • Acute psychosis (DSM-IV Criteria)
  • Rapid cycling in the past 1 year
  • Alcohol or substance abuse or dependence in the past 6 months.
  • Current symptoms of hypomania or mania i.e. ManiaRatingScale=5
  • Recent history of a suicide attempt (3 months) or active suicidal ideation (SIGH-ADS item H11=2 or more)
  • Treatment with propranolol (Inderal), exogenous melatonin, chronic NSAIDS.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Bipolar Depressed
Bipolar Depressed - are participants with Bipolar Disorder Type I or II and a current episode of major depression which is confirmed on the SCID interview
Healthy Comparator
Healthy Comparator - are participants without mental disorders, alcohol or substance disorders confirmed by the SCID-interview

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
visual evoked potentials (VEP) waveforms (mean amplitudes or latencies)
大体时间：Week 0 and Week 6
Visual Evoked Potential (VEP). This is a test which is used to assess visual cortical responses. The VEP recordings will be assessed at different contrast levels (80%, 16% and 7%) for the patient groups (BD vs HC). To assess the change in visual cortical responses, we will compare differences in the VEP responses between Weeks 0 and 6 between the groups.
Week 0 and Week 6
Electroretinography (ERG) waveforms (mean amplitudes or latencies)
大体时间：Week 0 and Week 6
Electroretinogram (ERG). This is a test which is used to assess electrical responses of the retina. The ERG recordings will be assessed at different contrast levels (80%, 16% and 7%) for the patient groups (BD vs HC). To assess the change in retinal responses, we will compare differences in ERG responses between Weeks 0 and 6 between the groups.
Week 0 and Week 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Northwestern University

合作者

University of Pittsburgh

调查人员

  • 首席研究员：Dorothy Sit, M.D.、University of Pittsburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2017年12月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2014年1月24日

首先提交符合 QC 标准的

2014年1月27日

首次发布 (估计)

2014年1月29日

研究记录更新

最后更新发布 (实际的)

2018年3月29日

上次提交的符合 QC 标准的更新

2018年3月27日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PRO14010387

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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