Clinical Trials Directory

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.