An interventional study of Light therapy in Major Depression in Remission, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.
Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment.
Light therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question.
Before conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.
Device: Light therapy
Light therapy
Adherence Rate
Rate of adherence (\>75% of total daily sessions) to light therapy
Time frame: 6 weeks
Relapse Rate
Relapse as defined.
Time frame: 6 weeks
Change in Clinician-rated Depressive Symptoms
Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).
Time frame: 6 weeks
Change in Patient-rated Depressive Symptoms
Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).
Time frame: 6 weeks
Discontinuation Symptoms
Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).
Time frame: 4 weeks
| Milestone | Light Therapy |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Rate of adherence (\>75% of total daily sessions) to light therapy
| participants | Light Therapy |
|---|---|
| Adherence Rate | 1 |
Relapse as defined.
| Participants | Light Therapy |
|---|---|
| Relapse Rate | 1 |
Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).
| score on a scale | Light Therapy |
|---|---|
| Change in Clinician-rated Depressive Symptoms | 22 |
Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).
| score on a scale | Light Therapy |
|---|---|
| Change in Patient-rated Depressive Symptoms | 14 |
Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).
| score on a scale | Light Therapy |
|---|---|
| Discontinuation Symptoms | 5 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Therapy | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Light Therapy |
|---|---|
| NauseaGastrointestinal disorders | 1/1 |
| HeadacheNervous system disorders | 1/1 |
| Eye strainEye disorders | 1/1 |
| Age, Categorical(Participants) | Light Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Light Therapy |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Light Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Light Therapy |
|---|---|
| Canada | 1 |
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University of British Columbia