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

This study has been completed.
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Dorothy Sit, Northwestern University
ClinicalTrials.gov Identifier:
NCT00852592
First received: February 25, 2009
Last updated: September 20, 2016
Last verified: September 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • SIGH-ADS Depression Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: We can share data if approached by other investigators

Keywords provided by 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 December 05, 2016