Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04944758
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2021-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of Adherence to Light Therapy
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We received a grant for an expanded feasibility trial that superseded this one.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: