Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker (LightEyeBD)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- Western Psychiatric Institute and Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Bipolar Depressed
Bipolar Depressed - are participants with Bipolar Disorder Type I or II and a current episode of major depression which is confirmed on the SCID interview
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Healthy Comparator
Healthy Comparator - are participants without mental disorders, alcohol or substance disorders confirmed by the SCID-interview
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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visual evoked potentials (VEP) waveforms (mean amplitudes or latencies)
기간: Week 0 and Week 6
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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.
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Week 0 and Week 6
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Electroretinography (ERG) waveforms (mean amplitudes or latencies)
기간: Week 0 and Week 6
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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.
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Week 0 and Week 6
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dorothy Sit, M.D., University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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