Trial Outcomes & Findings for Are Bright Lights and Regulated Sleep Effective Treatment for Depression? (NCT NCT03010488)
NCT ID: NCT03010488
Last Updated: 2021-03-23
Results Overview
Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression
COMPLETED
NA
44 participants
Week 6
2021-03-23
Participant Flow
Participant milestones
| Measure |
Rapid Sleep Shift
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
Gradual Sleep Shift
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
Baseline characteristics by cohort
| Measure |
Rapid Sleep Shift
n=22 Participants
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
Gradual Sleep Shift
n=22 Participants
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 14.3 • n=99 Participants
|
38.8 years
STANDARD_DEVIATION 16.4 • n=107 Participants
|
38.3 years
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
44 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.
Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression
Outcome measures
| Measure |
Rapid Sleep Shift
n=18 Participants
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
Gradual Sleep Shift
n=15 Participants
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
|---|---|---|
|
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)
|
8.66 units on a scale
Standard Deviation 6.09
|
10.46 units on a scale
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Week 6Population: Due to rater availability we weren't able to get independent evaluations on all participants. The numbers listed or the number we were able to get independent evaluations on.
Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs. Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day. Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.
Outcome measures
| Measure |
Rapid Sleep Shift
n=7 Participants
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing clear goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
Gradual Sleep Shift
n=7 Participants
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing amber (blue blocking) goggles.
Morning Light Therapy: 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep Times: Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
Goggles: Subjects will wear goggles during saliva collection and Bright Light Therapy
|
|---|---|---|
|
Participant Sleep Efficiency
|
76.43 percentage of time
Standard Deviation 10.82
|
68.23 percentage of time
Standard Deviation 28.27
|
Adverse Events
Rapid Sleep Shift
Gradual Sleep Shift
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place