Trials / Completed
CompletedNCT02048995
Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 91 (estimated)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2014-01-29
- Last updated
- 2018-03-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02048995. Inclusion in this directory is not an endorsement.