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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

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ClinicalTrials.gov Identifier: NCT01545843
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : January 30, 2015
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
J. Todd Arnedt, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Behavioral: Sleep scheduling
Drug: Fluoxetine
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description 8 hours time in bed for two weeks plus fluoxetine for 8 weeks 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours.
Period Title: Overall Study
Started 19 24 25
Completed 16 17 21
Not Completed 3 7 4
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 19 24 25 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 24 participants 25 participants 68 participants
26.4  (7.4) 24.4  (5.6) 25.7  (7.0) 25.4  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 25 participants 68 participants
Female
7
  36.8%
13
  54.2%
14
  56.0%
34
  50.0%
Male
12
  63.2%
11
  45.8%
11
  44.0%
34
  50.0%
1.Primary Outcome
Title Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
Hide Description 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.
Time Frame Post-treatment (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 19 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.1  (6.7) 8.1  (4.4) 6.3  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Sleep Deprivation, Late Bedtime Sleep Deprivation, Early Risetime Sleep Deprivation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .202
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Quick Inventory of Depressive Symptoms (QIDS)
Hide Description Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.
Time Frame Post-treatment (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

8 hours time in bed plus medication

Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

Overall Number of Participants Analyzed 19 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (4.7) 6.9  (3.3) 6.7  (4.5)
3.Secondary Outcome
Title Pittsburgh Sleep Quality Index
Hide Description 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.
Time Frame Baseline, 2 weeks and 8 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

8 hours time in bed plus medication

Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

Overall Number of Participants Analyzed 14 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 10 participants 12 participants 13 participants
6.00  (2.828) 8.67  (2.839) 6.85  (3.236)
Week 2 Number Analyzed 13 participants 14 participants 14 participants
5.23  (2.204) 6.07  (2.615) 5.50  (2.312)
Week 8 Number Analyzed 14 participants 13 participants 15 participants
4.86  (2.248) 6.23  (2.713) 6.33  (2.944)
4.Secondary Outcome
Title Change in EEG Sleep Measures I: Total Sleep Time
Hide Description 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.
Time Frame Baseline, 2 weeks, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 19 24 25
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 19 participants 24 participants 25 participants
430.132  (60.9230) 439.208  (36.3375) 444.040  (19.7283)
Week 2 Number Analyzed 17 participants 18 participants 22 participants
435.382  (25.7206) 337.75  (24.69) 332.909  (17.0480)
Week 8 Number Analyzed 15 participants 17 participants 21 participants
439.6  (19.5231) 428.264  (54.4570) 433.333  (35.0347)
5.Secondary Outcome
Title Change in EEG Sleep Measures II (Sleep Efficiency)
Hide Description Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100]
Time Frame Baseline, 2 weeks, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subsequent rows have lower numbers of participants analyzed due to participant flow and/or unusable data.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

8 hours time in bed plus medication

Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

Overall Number of Participants Analyzed 19 24 25
Mean (Standard Deviation)
Unit of Measure: percent of sleep time
Baseline Number Analyzed 19 participants 24 participants 25 participants
89.7005  (12.62820) 91.6829  (7.58117) 92.8248  (4.01214)
Week 2 Number Analyzed 17 participants 18 participants 22 participants
90.7824  (5.29745) 93.3322  (4.97614) 92.9082  (4.01214)
Week 8 Number Analyzed 15 participants 17 participants 21 participants
91.6153  (4.03518) 88.9224  (11.09279) 90.3838  (7.17430)
6.Secondary Outcome
Title Change in Neuropsychological Functioning: Memory
Hide Description Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Time Frame Baseline, 2 weeks, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

8 hours time in bed plus medication

Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

6 hours time in bed plus medication

Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime

Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks

Overall Number of Participants Analyzed 17 17 21
Mean (Standard Deviation)
Unit of Measure: words
Baseline Number Analyzed 17 participants 16 participants 21 participants
77.118  (17.1569) 74.938  (10.2337) 76.095  (13.4458)
Week 2 Number Analyzed 17 participants 17 participants 20 participants
76.647  (15.0829) 81.529  (10.1311) 77.400  (13.8579)
Week 8 Number Analyzed 13 participants 15 participants 15 participants
73.923  (12.1481) 79.733  (7.4399) 81.200  (14.1885)
7.Secondary Outcome
Title Change in Neurologic Functioning: Reaction Time
Hide Description Reaction Time is measured using a modified Go/No-go test of inhibitory control
Time Frame 0, 2, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 21
Mean (Standard Deviation)
Unit of Measure: milliseconds
Week 0 (Baseline) Number Analyzed 17 participants 16 participants 21 participants
499.1545  (65.66508) 528.3513  (135.86747) 470.2942  (61.65017)
Week 2 Number Analyzed 17 participants 17 participants 20 participants
493.2579  (58.64806) 519.8196  (60.68815) 472.7244  (56.51599)
Week 8 Number Analyzed 13 participants 15 participants 21 participants
483.7349  (55.33537) 557.1635  (188.22995) 500.1197  (148.46524)
8.Secondary Outcome
Title Neurological Function (Emotional Perception)
Hide Description Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)
Time Frame 0 weeks, 2 weeks, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
At some time points, some participants did not show up to appointments or allow a particular test to be employed.
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 17 17 21
Mean (Standard Deviation)
Unit of Measure: percentage of emotions accurately ID'ed
0 weeks (Baseline) Number Analyzed 17 participants 15 participants 21 participants
83.54  (10.549) 86.24  (6.721) 88.83  (7.321)
Week 2 Number Analyzed 17 participants 17 participants 21 participants
83.08  (6.938) 88.15  (6.159) 88.75  (7.099)
Week 8 Number Analyzed 12 participants 15 participants 21 participants
85.95  (8.585) 89.15  (4.724) 87.74  (4.708)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events judged to be related to the study and of moderate or greater severity
 
Arm/Group Title No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Hide Arm/Group Description

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

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

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

All-Cause Mortality
No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/24 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Sleep Deprivation Late Bedtime Sleep Deprivation Early Risetime Sleep Deprivation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      5/24 (20.83%)      0/25 (0.00%)    
Gastrointestinal disorders       
Medication side effects * [1]  0/19 (0.00%)  0 3/24 (12.50%)  3 0/25 (0.00%)  0
Psychiatric disorders       
Mood worsening *  0/19 (0.00%)  0 2/24 (8.33%)  2 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Medication side effects judged to be moderately severe
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. J. Todd Arnedt
Organization: University of Michigan
Phone: 734-764-1234
Responsible Party: J. Todd Arnedt, University of Michigan
ClinicalTrials.gov Identifier: NCT01545843     History of Changes
Other Study ID Numbers: R01MH077690 ( U.S. NIH Grant/Contract )
First Submitted: January 12, 2012
First Posted: March 7, 2012
Results First Submitted: January 13, 2015
Results First Posted: January 30, 2015
Last Update Posted: December 8, 2017