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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


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
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