Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/17/2018 |
| Start Date: | February 2014 |
| End Date: | December 2017 |
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.
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.
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.
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.
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.
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