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

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

Detailed Description
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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.

Official Title
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Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

Conditions
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Bipolar Disorder, Major Depressive Episode

Intervention / Treatment
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* Device: 7000lux broad-spectrum light
* Device: 50lux dim red light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>7000lux broad-spectrum light | Device: 7000lux broad-spectrum light<br>* dosage - 15-60minutes NOON-2PM daily<br>|
| Placebo Comparator: Inactive Comparator<br>50lux dim red light | Device: 50lux dim red light<br>* dosage: 15-60minutes NOON-2PM daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH-ADS Depression Score | 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. | 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II