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

This study is currently recruiting participants.
Verified February 2011 by University of Pittsburgh
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00852592
First received: February 25, 2009
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Major Depressive Disorder, Single Episode, Unspecified
 Device: active light therapy unit
Device: Inactive light therapy unit
 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:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator
active light unit
 Device: active light therapy unit
dosage - 15-60minutes NOON-2PM daily
Placebo Comparator: Inactive Comparator
inactive light unit
 Device: Inactive light therapy unit
dosage: 15-60minutes NOON-2PM daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852592

Contacts
Contact: Dorothy Sit, M.D. 412-246-5248 sitdk@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jonathan Weingarden, B.S.     412-246-5346     weingardenj@upmc.edu    
Contact: Dorothy Sit, M.D.     412-246-5248     sitdk@upmc.edu    
Principal Investigator: Dorothy Sit, M.D.            
University of Pittsburgh, Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dorothy Sit, M.D.     800-436-2461     sitdk@upmc.edu    
Contact: Neil Amina     412-246-5346     aminan@upmc.edu    
Principal Investigator: Dorothy Sit, M.D.            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dorothy K Sit, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dorothy Sit, M.D. Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00852592     History of Changes
Other Study ID Numbers: PRO09020546, NIMH# 1 K23 MH082114-01A2
Study First Received: February 25, 2009
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bipolar Disorder Depression Midday Light Therapy
Bipolar Disorder Type I or II

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
 Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013