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

Completed

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT02048995

Run by

Northwestern University

People needed

91

Starts

2014-02-01

Expected to finish

2017-12-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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