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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852592
• Other study ID #: PRO09020546
• Secondary ID: NIMH# 1 K23 MH08
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2009
• Last updated: May 26, 2015
• Start date: May 2009
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder, Major
• Major Depressive Episode

Intervention

Device:
• active light therapy unit
dosage - 15-60minutes NOON-2PM daily
• Inactive light therapy unit
dosage: 15-60minutes NOON-2PM daily

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pittsburgh, Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous depression ratings on the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) instrument		Weekly measures in the Acute Phase Weeks 1-6	Yes