NCT04944758

Feasibility of Adherence to Light Therapy

Terminated NA Results posted Last updated 30 May 2024

What this trial tests

NA trial testing Light therapy in Major Depression in Remission in 1 participant. Terminated before completion.

Timeline

21 April 2022

Primary endpoint
21 June 2022

21 June 2022

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1
Start date	21 April 2022
Primary completion	21 June 2022
Estimated completion	21 June 2022
Sites	1 location across Canada

Drugs / interventions tested

• Light therapy

Conditions studied

• Major Depression in Remission — all drugs for Major Depression in Remission →

Sponsor

University of British Columbia

Who can join

Adults 19 to 65, any sex, with Major Depression in Remission. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence Rate Primary · 6 weeks

Rate of adherence (\>75% of total daily sessions) to light therapy

Group	Value	95% CI
Light Therapy	1

Relapse Rate Secondary · 6 weeks

Relapse as defined.

Group	Value	95% CI
Light Therapy	1

Change in Clinician-rated Depressive Symptoms Secondary · 6 weeks

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).

Group	Value	95% CI
Light Therapy	22

Change in Patient-rated Depressive Symptoms Secondary · 6 weeks

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).

Group	Value	95% CI
Light Therapy	14

Discontinuation Symptoms Secondary · 4 weeks

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).

Group	Value	95% CI
Light Therapy	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Light Therapy

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (3 terms — click to expand)

Reaction	System	Light Therapy
Nausea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Eye strain	Eye disorders	—

Data from ClinicalTrials.gov NCT04944758 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.