Trial Outcomes & Findings for Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression (NCT NCT01545843)
NCT ID: NCT01545843
Last Updated: 2023-01-30
Results Overview
Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Post-treatment (8 weeks)
Results posted on
2023-01-30
Participant Flow
Participant milestones
| Measure |
No Sleep Deprivation
8 hours time in bed for two weeks plus fluoxetine for 8 weeks
|
Late Bedtime Sleep Deprivation
6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
|
Early Risetime Sleep Deprivation
6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
24
|
25
|
|
Overall Study
COMPLETED
|
16
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Baseline characteristics by cohort
| Measure |
No Sleep Deprivation
n=19 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for two weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 Participants
6 hours time in bed plus medication
Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 Participants
6 hours time in bed plus medication
Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (8 weeks)Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.
Outcome measures
| Measure |
No Sleep Deprivation
n=19 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
|
6.1 units on a scale
Standard Deviation 6.7
|
8.1 units on a scale
Standard Deviation 4.4
|
6.3 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Post-treatment (8 weeks)Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.
Outcome measures
| Measure |
No Sleep Deprivation
n=19 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptoms (QIDS)
|
5.3 units on a scale
Standard Deviation 4.7
|
6.9 units on a scale
Standard Deviation 3.3
|
6.7 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 8 weeks post-treatmentPopulation: At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.
Outcome measures
| Measure |
No Sleep Deprivation
n=14 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=14 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=15 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index
Baseline
|
6.00 units on a scale
Standard Deviation 2.828
|
8.67 units on a scale
Standard Deviation 2.839
|
6.85 units on a scale
Standard Deviation 3.236
|
|
Pittsburgh Sleep Quality Index
Week 2
|
5.23 units on a scale
Standard Deviation 2.204
|
6.07 units on a scale
Standard Deviation 2.615
|
5.50 units on a scale
Standard Deviation 2.312
|
|
Pittsburgh Sleep Quality Index
Week 8
|
4.86 units on a scale
Standard Deviation 2.248
|
6.23 units on a scale
Standard Deviation 2.713
|
6.33 units on a scale
Standard Deviation 2.944
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 8 weeksPopulation: Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data.
Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.
Outcome measures
| Measure |
No Sleep Deprivation
n=19 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Change in EEG Sleep Measures I: Total Sleep Time
Baseline
|
430.132 minutes
Standard Deviation 60.9230
|
439.208 minutes
Standard Deviation 36.3375
|
444.040 minutes
Standard Deviation 19.7283
|
|
Change in EEG Sleep Measures I: Total Sleep Time
Week 2
|
435.382 minutes
Standard Deviation 25.7206
|
337.75 minutes
Standard Deviation 24.69
|
332.909 minutes
Standard Deviation 17.0480
|
|
Change in EEG Sleep Measures I: Total Sleep Time
Week 8
|
439.6 minutes
Standard Deviation 19.5231
|
428.264 minutes
Standard Deviation 54.4570
|
433.333 minutes
Standard Deviation 35.0347
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 8 weeksPopulation: Subsequent rows have lower numbers of participants analyzed due to participant flow and/or unusable data.
Measurement of EEG activity during sleep using polysomnography: Sleep efficiency \[(total sleep time/time in bed)\*100\]
Outcome measures
| Measure |
No Sleep Deprivation
n=19 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Change in EEG Sleep Measures II (Sleep Efficiency)
Baseline
|
89.7005 percent of sleep time
Standard Deviation 12.62820
|
91.6829 percent of sleep time
Standard Deviation 7.58117
|
92.8248 percent of sleep time
Standard Deviation 4.01214
|
|
Change in EEG Sleep Measures II (Sleep Efficiency)
Week 2
|
90.7824 percent of sleep time
Standard Deviation 5.29745
|
93.3322 percent of sleep time
Standard Deviation 4.97614
|
92.9082 percent of sleep time
Standard Deviation 4.01214
|
|
Change in EEG Sleep Measures II (Sleep Efficiency)
Week 8
|
91.6153 percent of sleep time
Standard Deviation 4.03518
|
88.9224 percent of sleep time
Standard Deviation 11.09279
|
90.3838 percent of sleep time
Standard Deviation 7.17430
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 8 weeksPopulation: At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Outcome measures
| Measure |
No Sleep Deprivation
n=17 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=17 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=21 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Change in Neuropsychological Functioning: Memory
Baseline
|
77.118 words
Standard Deviation 17.1569
|
74.938 words
Standard Deviation 10.2337
|
76.095 words
Standard Deviation 13.4458
|
|
Change in Neuropsychological Functioning: Memory
Week 2
|
76.647 words
Standard Deviation 15.0829
|
81.529 words
Standard Deviation 10.1311
|
77.400 words
Standard Deviation 13.8579
|
|
Change in Neuropsychological Functioning: Memory
Week 8
|
73.923 words
Standard Deviation 12.1481
|
79.733 words
Standard Deviation 7.4399
|
81.200 words
Standard Deviation 14.1885
|
SECONDARY outcome
Timeframe: 0, 2, 8 weeksPopulation: At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Reaction Time is measured using a modified Go/No-go test of inhibitory control
Outcome measures
| Measure |
No Sleep Deprivation
n=17 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=17 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=21 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Change in Neurologic Functioning: Reaction Time
Week 0 (Baseline)
|
499.1545 milliseconds
Standard Deviation 65.66508
|
528.3513 milliseconds
Standard Deviation 135.86747
|
470.2942 milliseconds
Standard Deviation 61.65017
|
|
Change in Neurologic Functioning: Reaction Time
Week 2
|
493.2579 milliseconds
Standard Deviation 58.64806
|
519.8196 milliseconds
Standard Deviation 60.68815
|
472.7244 milliseconds
Standard Deviation 56.51599
|
|
Change in Neurologic Functioning: Reaction Time
Week 8
|
483.7349 milliseconds
Standard Deviation 55.33537
|
557.1635 milliseconds
Standard Deviation 188.22995
|
500.1197 milliseconds
Standard Deviation 148.46524
|
SECONDARY outcome
Timeframe: 0 weeks, 2 weeks, 8 weeksPopulation: At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)
Outcome measures
| Measure |
No Sleep Deprivation
n=17 Participants
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for 2 weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=17 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=21 Participants
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Neurological Function (Emotional Perception)
0 weeks (Baseline)
|
83.54 percentage of emotions accurately ID'ed
Standard Deviation 10.549
|
86.24 percentage of emotions accurately ID'ed
Standard Deviation 6.721
|
88.83 percentage of emotions accurately ID'ed
Standard Deviation 7.321
|
|
Neurological Function (Emotional Perception)
Week 2
|
83.08 percentage of emotions accurately ID'ed
Standard Deviation 6.938
|
88.15 percentage of emotions accurately ID'ed
Standard Deviation 6.159
|
88.75 percentage of emotions accurately ID'ed
Standard Deviation 7.099
|
|
Neurological Function (Emotional Perception)
Week 8
|
85.95 percentage of emotions accurately ID'ed
Standard Deviation 8.585
|
89.15 percentage of emotions accurately ID'ed
Standard Deviation 4.724
|
87.74 percentage of emotions accurately ID'ed
Standard Deviation 4.708
|
Adverse Events
No Sleep Deprivation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Bedtime Sleep Deprivation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Early Risetime Sleep Deprivation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Sleep Deprivation
n=19 participants at risk
8 hours time in bed plus medication
Sleep scheduling: 8 hours time in bed for two weeks
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Late Bedtime Sleep Deprivation
n=24 participants at risk
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
Early Risetime Sleep Deprivation
n=25 participants at risk
6 hours time in bed plus medication
Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime
Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Medication side effects
|
0.00%
0/19
Adverse events judged to be related to the study and of moderate or greater severity
|
12.5%
3/24 • Number of events 3
Adverse events judged to be related to the study and of moderate or greater severity
|
0.00%
0/25
Adverse events judged to be related to the study and of moderate or greater severity
|
|
Psychiatric disorders
Mood worsening
|
0.00%
0/19
Adverse events judged to be related to the study and of moderate or greater severity
|
8.3%
2/24 • Number of events 2
Adverse events judged to be related to the study and of moderate or greater severity
|
0.00%
0/25
Adverse events judged to be related to the study and of moderate or greater severity
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place