Clinical trial NCT02048995: Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker
Official title: Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Depression
Keywords: Bipolar Disorder
Depression
Light Therapy
Contrast Sensitivity
Visual Evoked Potential
Visual or Neural Responses
Biomarker
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2014-01-29
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community patient sample

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: visual evoked potentials (VEP) waveforms (mean amplitudes or latencies)
timeFrame: Week 0 and Week 6
measure: Electroretinography (ERG) waveforms (mean amplitudes or latencies)
timeFrame: Week 0 and Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dorothy Sit, M.D.
role: PRINCIPAL_INVESTIGATOR
References: