Clinical trial NCT00852592: Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Official title: Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Major Depressive Episode
Keywords: Bipolar Disorder Depression Midday Light Therapy
Bipolar Disorder Type I or II
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2009-02-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SIGH-ADS Depression Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Global Assessment of Functioning (GAF)
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Western Psychiatric Institute and Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dorothy K Sit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.