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

This study is currently recruiting participants.
Verified January 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Dorothy Sit, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00852592
First received: February 25, 2009
Last updated: January 24, 2014
Last verified: January 2014
  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: 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:


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: April 2014
Estimated Primary Completion Date: April 2014 (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: Dorothy Sit    412-246-5248    sitdk@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, 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: January 24, 2014
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 April 16, 2014