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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 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Dorothy Sit, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 25, 2009
First Posted Date  ICMJE February 27, 2009
Results First Submitted Date  ICMJE February 19, 2016
Results First Posted Date  ICMJE November 6, 2016
Last Update Posted Date November 6, 2016
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
Continuous depression ratings on the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) instrument [ Time Frame: Weekly measures in the Acute Phase Weeks 1-6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Official Title  ICMJE Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Major Depressive Episode
Intervention  ICMJE
  • Device: 7000lux broad-spectrum light
    dosage - 15-60minutes NOON-2PM daily
  • Device: 50lux dim red light
    dosage: 15-60minutes NOON-2PM daily
Study Arms  ICMJE
  • Active Comparator: Active Comparator
    7000lux broad-spectrum light
    Intervention: Device: 7000lux broad-spectrum light
  • Placebo Comparator: Inactive Comparator
    50lux dim red light
    Intervention: Device: 50lux dim red light
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
80
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00852592
Other Study ID Numbers  ICMJE PRO09020546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We can share data if approached by other investigators
Current Responsible Party Dorothy Sit, Northwestern University
Original Responsible Party Dorothy Sit, M.D. Assistant Professor of Psychiatry, University of Pittsburgh
Current Study Sponsor  ICMJE Northwestern University
Original Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Dorothy K Sit, M.D. University of Pittsburgh
PRS Account Northwestern University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP