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

NCT ID: NCT02048995

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Bipolar Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Healthy Comparator

Healthy Comparator - are participants without mental disorders, alcohol or substance disorders confirmed by the SCID-interview

No interventions assigned to this group

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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Dorothy Sit

Associate Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorothy Sit, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO14010387

Identifier Type: -

Identifier Source: org_study_id