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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dorothy Sit, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00852592
First received: February 25, 2009
Last updated: May 26, 2015
Last verified: May 2015
  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 ]

Enrollment: 80
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
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
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
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
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: May 26, 2015
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
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on August 27, 2015