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

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ClinicalTrials.gov Identifier: NCT00852592
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : May 2009
Primary Completion Date : December 2014
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 27, 2009    Key Record Dates
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016
Last Verified: September 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