Trial Outcomes & Findings for Feasibility of Adherence to Light Therapy (NCT NCT04944758)

NCT ID: NCT04944758

Last Updated: 2024-05-30

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Light Therapy 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. Light therapy: Light therapy
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Adherence to Light Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Adherence Rate	1 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: This is a defined event, "relapse", which is based on several criteria, only one of which is the MADRS scale; however this scale does NOT represent part of the outcome and so is not reported here..

Relapse as defined.

Outcome measures

Outcome measures
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Relapse Rate	1 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Change in Clinician-rated Depressive Symptoms	22 score on a scale

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Change in Patient-rated Depressive Symptoms	14 score on a scale

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Light Therapy n=1 Participants 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. Light therapy: Light therapy
Discontinuation Symptoms	5 score on a scale

Adverse Events

Light Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Light Therapy n=1 participants at risk 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. Light therapy: Light therapy
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • 8 weeks
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • 8 weeks
Eye disorders Eye strain	100.0% 1/1 • Number of events 1 • 8 weeks

Additional Information

Dr. Raymond Lam

University of British Columbia

Phone: 6048227325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place