Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
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ClinicalTrials.gov Identifier: NCT00852592 |
Recruitment Status :
Completed
First Posted : February 27, 2009
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder Major Depressive Episode | Device: 7000lux broad-spectrum light Device: 50lux dim red light | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active Comparator
7000lux broad-spectrum light
|
Device: 7000lux broad-spectrum light
dosage - 15-60minutes NOON-2PM daily |
Placebo Comparator: Inactive Comparator
50lux dim red light
|
Device: 50lux dim red light
dosage: 15-60minutes NOON-2PM daily |
- SIGH-ADS Depression Score [ Time Frame: 6 weeks ]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.
- Global Assessment of Functioning (GAF) [ Time Frame: 6-weeks ]The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852592
United States, Pennsylvania | |
University of Pittsburgh, Western Psychiatric Institute and Clinic | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Dorothy K Sit, M.D. | University of Pittsburgh |
Responsible Party: | Dorothy Sit, Associate Professor of Psychiatry and Behavioral Sciences, Northwestern University |
ClinicalTrials.gov Identifier: | NCT00852592 |
Other Study ID Numbers: |
PRO09020546 |
First Posted: | February 27, 2009 Key Record Dates |
Results First Posted: | November 6, 2016 |
Last Update Posted: | November 6, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | We can share data if approached by other investigators |
Bipolar Disorder Depression Midday Light Therapy Bipolar Disorder Type I or II |
Depression Bipolar Disorder Behavioral Symptoms Mental Disorders Bipolar and Related Disorders |