Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
September 20, 2016 updated by: Dorothy Sit, Northwestern University
Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh, Western Psychiatric Institute and Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Comparator
7000lux broad-spectrum light
|
dosage - 15-60minutes NOON-2PM daily
|
|
Placebo Comparator: Inactive Comparator
50lux dim red light
|
dosage: 15-60minutes NOON-2PM daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dorothy K Sit, M.D., University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 26, 2009
First Posted (Estimate)
February 27, 2009
Study Record Updates
Last Update Posted (Estimate)
November 6, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09020546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We can share data if approached by other investigators
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.