Back to results

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

Primary Purpose

Bipolar Disorder, Major Depressive Episode

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

7000lux broad-spectrum light

50lux dim red light

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh, Western Psychiatric Institute and Clinic
University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator

Inactive Comparator

Arm Description

7000lux broad-spectrum light

50lux dim red light

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Global Assessment of Functioning (GAF)

The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.

Full Information

NCT ID

NCT00852592

First Posted

February 25, 2009

Last Updated

September 20, 2016

Sponsor

Northwestern University

Collaborators

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT00852592

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

University of Pittsburgh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Major Depressive Episode

Keywords

Bipolar Disorder Depression Midday Light Therapy, Bipolar Disorder Type I or II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

7000lux broad-spectrum light

Arm Title

Inactive Comparator

Arm Type

Placebo Comparator

Arm Description

50lux dim red light

Intervention Type

Device

Intervention Name(s)

7000lux broad-spectrum light

Intervention Description

dosage - 15-60minutes NOON-2PM daily

Intervention Type

Device

Intervention Name(s)

50lux dim red light

Intervention Description

dosage: 15-60minutes NOON-2PM daily

Primary Outcome Measure Information:

Title

SIGH-ADS Depression Score

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Global Assessment of Functioning (GAF)

Description

The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.

Time Frame

6-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorothy K Sit, M.D.

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh, Western Psychiatric Institute and Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We can share data if approached by other investigators

Citations:

PubMed Identifier

28969438

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs