Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to understand the efficacy of light therapy for bipolar depression.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder; Major Depressive Episode	Device: 7000lux broad-spectrum light; Device: 50lux dim red light	Phase 3

Detailed Description:

Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	46 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Study Start Date :	May 2009
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	February 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Active Comparator; 7000lux broad-spectrum light	Device: 7000lux broad-spectrum light; dosage - 15-60minutes NOON-2PM daily
Placebo Comparator: Inactive Comparator; 50lux dim red light	Device: 50lux dim red light; dosage: 15-60minutes NOON-2PM daily

Outcome Measures

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Primary Outcome Measures :

1. SIGH-ADS Depression Score [ Time Frame: 6 weeks ]
   The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.

Secondary Outcome Measures :

1. Global Assessment of Functioning (GAF) [ Time Frame: 6-weeks ]
   The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Ages 18-65 years
• DSM-IV Criteria BD I or II depressive episode,
• SIGH-ADS >20; duration >2 weeks.
• Stable dose antidepressant drug >8 weeks with concurrent antimanic drug
• Controlled thyroid disease
• Subjects with preexisting eye diseases will be included.
• Able to provide informed consent
• Stable minimum dose antimanic drug >4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
• Stable unchanged psychotherapy for >16weeks

Exclusion Criteria:

• The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
• Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
• Acute psychosis (DSM-IV Criteria)
• Rapid cycling in the past 1 year
• Obsessive compulsive disorder
• Alcohol or substance abuse or dependence in the past 6 months.
• MRS>5
• Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 >2)
• Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Northwestern University

University of Pittsburgh

Investigators

Principal Investigator:	Dorothy K Sit, M.D.	University of Pittsburgh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dorothy Sit, Associate Professor of Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier:	NCT00852592 History of Changes
Other Study ID Numbers:	PRO09020546
First Posted:	February 27, 2009
Results First Posted:	November 7, 2016
Last Update Posted:	November 7, 2016
Last Verified:	September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	We can share data if approached by other investigators

Keywords provided by Dorothy Sit, Northwestern University:

Bipolar Disorder Depression Midday Light Therapy; Bipolar Disorder Type I or II

Additional relevant MeSH terms:

Disease; Depression; Bipolar Disorder; Depressive Disorder, Major; Pathologic Processes	Behavioral Symptoms; Bipolar and Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders