Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial - Full Text View

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder Major Depressive Episode	Device: 7000lux broad-spectrum light Device: 50lux dim red light	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: bipolar disorder

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Further study details as provided by Dorothy Sit, Northwestern University:

Primary Outcome Measures:

SIGH-ADS Depression Score [ Time Frame: 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:

Global Assessment of Functioning (GAF) [ Time Frame: 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.


Enrollment:	46
Study Start Date:	May 2009
Study Completion Date:	February 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Comparator 7000lux broad-spectrum light	Device: 7000lux broad-spectrum light dosage - 15-60minutes NOON-2PM daily
Placebo Comparator: Inactive Comparator 50lux dim red light	Device: 50lux dim red light dosage: 15-60minutes NOON-2PM daily

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852592

Locations


United States, Pennsylvania
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Northwestern University

University of Pittsburgh

Investigators


Principal Investigator:	Dorothy K Sit, M.D.	University of Pittsburgh

More Information


Responsible Party:	Dorothy Sit, Associate Professor of Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier:	NCT00852592 History of Changes
Other Study ID Numbers:	PRO09020546
Study First Received:	February 25, 2009
Results First Received:	February 19, 2016
Last Updated:	September 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	We can share data if approached by other investigators

Keywords provided by Dorothy Sit, Northwestern University:


Bipolar Disorder Depression Midday Light Therapy Bipolar Disorder Type I or II

Additional relevant MeSH terms:


Disease Depression Bipolar Disorder Depressive Disorder, Major Pathologic Processes	Behavioral Symptoms Bipolar and Related Disorders Mental Disorders Depressive Disorder Mood Disorders

ClinicalTrials.gov processed this record on September 18, 2017