Bright light therapy for bipolar depression with eveningness
A Randomized Placebo-controlled Trial for Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness
This study is testing if bright light therapy can help people with bipolar depression who have trouble with their sleep patterns feel better over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05357313 on ClinicalTrials.gov |
What this trial studies
This randomized placebo-controlled trial investigates the effectiveness of six weeks of bright light therapy (BLT) as an additional treatment for patients experiencing bipolar depression and eveningness. Participants will be randomly assigned to receive either BLT or a placebo treatment using an inactive negative ion generator for 30 minutes daily at their usual wake time. The study aims to assess changes in depressive symptoms and sleep-wake patterns through evaluations at baseline, and at the 2nd, 4th, and 6th weeks of treatment. Actigraphy will also be utilized to monitor sleep disturbances before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of bipolar depression who exhibit eveningness and are on stable antimanic treatment.
Not a fit: Patients with Major Depressive Disorder that has a seasonal pattern or those with a history of rapid-cycling may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce depressive symptoms and improve sleep quality for patients with bipolar depression.
How similar studies have performed: Other studies have shown promising results with bright light therapy for mood disorders, suggesting potential efficacy in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-65 years. 2. Is capable to give informed consent. 3. Meeting the diagnostic criteria of bipolar depression (including both bipolar I and II disorders) by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), Disorders (SCID-V). 4. a score 20 or above representing current moderate or severe episode of major depression and a score of at least 1 on items H1 or H2 on the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS), corresponding to at least moderate severity. 5. A score of 41 or less by the Morningness-Eveningness Questionnaire which represents eveningness. 6. On a stable dose of antimanic treatment for bipolar disorder for at least four weeks. Exclusion Criteria: 1. Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder). 2. A past history of rapid-cycling within the past twelve months or a Young Mania Rating Scale more than 12 at screening 3. A current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder. 4. Presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments. 5. Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications such as St. John's wart; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma, and photosensitive skin condition e.g. systemic lupus erythematosus 6. Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview. 7. Regular shift-workers or trans-meridian flight in the past 3 months or during study 8. Enrolment in another clinical trial of an investigational medicinal product or device. 9. Receiving regular psychotherapy.
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Joey WY Chan
- Email: joeywychan@cuhk.edu.hk
- Phone: +852 39197647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.