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

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.

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

visual evoked potentials (VEP) waveforms (mean amplitudes or latencies)

Time frame: 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.
Electroretinography (ERG) waveforms (mean amplitudes or latencies)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

University of Pittsburgh

Registry information

Acronym: LightEyeBD

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 29, 2014
Registry last updated: Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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