Status:
COMPLETED
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Bipolar Disorder
Major Depressive Episode
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00852592
Start Date
May 1 2009
End Date
February 1 2015
Last Update
November 7 2016
Active Locations (2)
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1
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213