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

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Northwestern University

Status and phase

Completed
Phase 3

Conditions

Major Depressive Episode
Bipolar Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00852592
PRO09020546

Details and patient eligibility

About

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

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

46 participants in 2 patient groups, including a placebo group

Active Comparator
Active Comparator group
Description:
7000lux broad-spectrum light
Treatment:
Device: 7000lux broad-spectrum light
Inactive Comparator
Placebo Comparator group
Description:
50lux dim red light
Treatment:
Device: 50lux dim red light

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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