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

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 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:

MedlinePlus related topics: Bipolar Disorder

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 ]


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 (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

University of Pittsburgh

Investigators


Principal Investigator:	Dorothy K Sit, M.D.	University of Pittsburgh

More Information


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:


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 September 29, 2016

To Top