NCT00852592

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

September 1, 2016

Enrollment Period

5.6 years

First QC Date

February 25, 2009

Results QC Date

February 19, 2016

Last Update Submit

September 20, 2016

Conditions

Bipolar DisorderMajor Depressive Episode

Keywords

Bipolar Disorder Depression Midday Light TherapyBipolar Disorder Type I or II

Outcome Measures

Primary Outcomes (1)

  • SIGH-ADS Depression Score

    The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.

    6 weeks

Secondary Outcomes (1)

  • Global Assessment of Functioning (GAF)

    6-weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

7000lux broad-spectrum light

Device: 7000lux broad-spectrum light

Inactive Comparator

PLACEBO COMPARATOR

50lux dim red light

Device: 50lux dim red light

Interventions

7000lux broad-spectrum lightDEVICE

dosage - 15-60minutes NOON-2PM daily

Active Comparator
50lux dim red lightDEVICE

dosage: 15-60minutes NOON-2PM daily

Inactive Comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.

    PMID: 28969438DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Assistant Professor of Psychiatry
Organization
UPittsburgh
sitdk@upmc.edu
412-246-5248

Study Officials

  • Dorothy K Sit, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 27, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

November 7, 2016

Results First Posted

November 7, 2016

Record last verified: 2016-09

Locations

US(2)