Feasibility of Adherence to Light Therapy

Major Depression in Remission Clinical Trial

Official title:

A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944758
• Other study ID #: V2.0_May-17-2021
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: Research Coordinator
• Phone: 604-822-8012
• Email: samantha.huang[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• [1] Outpatients 19 to 65 years of age;
• [2] DSM-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
• [3] taking an antidepressant for no more than six months;
• [4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
• [5] total score =10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS];
• [6] Willing and able to complete self-report and online assessments including sufficient fluency in English.

Exclusion Criteria:

• [1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
• [2] MDD with psychotic features (lifetime);
• [3] significant personality disorder diagnosis [e.g., borderline, antisocial];
• [4] High suicidal risk, defined by clinician judgment;
• [5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;
• [6] Significant neurological disorders, head trauma, or other unstable medical conditions;
• [7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);
• [8] history of severe withdrawal effects with antidepressant discontinuation;
• [9] retinal disease or other eye condition preventing use of bright light therapy;
• [10] use of photosensitizing medication within 1 week of baseline visit.

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression in Remission

Intervention

Device:
• Light therapy
Light therapy

Locations

Country	Name	City	State
Canada	UBC Mood Disorders Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Michael Smith Foundation for Health Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Rate of adherence (>75% of total daily sessions) to light therapy	12 weeks
Secondary	Relapse rate	Relapse will be defined as any of the following: [1] MADRS total score =22 for at least 2 consecutive weeks. If the relapse criterion of MADRS total score =22 is met at a scheduled assessment visit or an unscheduled relapse-assessment visit, an additional visit (i.e., the relapse-verification visit) will be scheduled within 1 to 2 weeks to verify the relapse; [2] Hospitalization for worsening of depression; [3] Suicidal ideation with intent, or suicidal behavior; [4] Any change in treatment (e.g., starting an antidepressant).	12 weeks
Secondary	Change in clinician-rated depressive symptoms	Changes in scores from baseline to 12 weeks on the Montgomery-Asberg Depression Rating Scale.	12 weeks
Secondary	Change in patient-rated depressive symptoms	Changes in scores from baseline to 12 weeks on the Quick Inventory of Depressive Symptomatology, Self-Rated scale.	12 weeks
Secondary	Discontinuation symptoms	Scores on a discontinuation effects scale developed for this study.	4, 8, 12 weeks