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

Phase 3

Completed

Interventions: Device: 50lux dim red light
Device: 7000lux broad-spectrum light

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Inactive Comparator	50lux dim red light	50lux dim red light
Active Comparator	7000lux broad-spectrum light	7000lux broad-spectrum light

Primary Outcome Measures

Name	Time	Method
SIGH-ADS Depression Score	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

Name	Time	Method
Global Assessment of Functioning (GAF)	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.

Locations (2): University of Pittsburgh, Western Psychiatric Institute and Clinic
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States