Phase 3 N=46 Randomized Triple-blind Treatment

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

Bipolar Disorder · Major Depressive Episode

Bottom Line

View on ClinicalTrials.gov: NCT00852592 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: SIGH-ADS Depression Score — 10.3; 17.3 units on a scale — p==0.005

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 7000lux broad-spectrum light (Device); 50lux dim red light (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY SIGH-ADS Depression Score	10.3; 17.3	=0.005 sig
SECONDARY Global Assessment of Functioning (GAF)	73.9; 65.2	=0.004 sig

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00852592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.