Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.
New treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.
Participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No sleep deprivation | Active Comparator | Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks |
|
| Late bedtime sleep deprivation | Experimental | Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours. |
|
| Early risetime sleep deprivation | Experimental | Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep scheduling | Behavioral | 8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression-17 Item Minus Sleep Items | 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. | Post-treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptoms (QIDS) | Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression. | Post-treatment (8 weeks) |
| Pittsburgh Sleep Quality Index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J. Todd Arnedt, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27529765 | Derived | Arnedt JT, Swanson LM, Dopp RR, Bertram HS, Mooney AJ, Huntley ED, Hoffmann RF, Armitage R. Effects of Restricted Time in Bed on Antidepressant Treatment Response: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1218-e1225. doi: 10.4088/JCP.15m09879. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Sleep Deprivation | 8 hours time in bed for two weeks plus fluoxetine for 8 weeks |
| FG001 | Late Bedtime Sleep Deprivation | 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours. |
| FG002 | Early Risetime Sleep Deprivation | 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Sleep Deprivation | 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 |
| BG001 | Late Bedtime Sleep Deprivation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression-17 Item Minus Sleep Items | 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. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (8 weeks) |
|
Not provided
Adverse events judged to be related to the study and of moderate or greater severity
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Sleep Deprivation | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication side effects | Gastrointestinal disorders | Non-systematic Assessment | Medication side effects judged to be moderately severe |
Sample is largely young, healthy adults
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Todd Arnedt | University of Michigan | 734-764-1234 | tarnedt@med.umich.edu |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluoxetine | Drug | 20-40 mg fluoxetine daily for 8 weeks |
|
|
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. |
| Baseline, 2 weeks and 8 weeks post-treatment |
| Change in EEG Sleep Measures I: Total Sleep Time | 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. | Baseline, 2 weeks, 8 weeks |
| Change in EEG Sleep Measures II (Sleep Efficiency) | Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100] | Baseline, 2 weeks, 8 weeks |
| Change in Neuropsychological Functioning: Memory | Change in different aspects of thinking (e.g., memory, attention, executive functioning) | Baseline, 2 weeks, 8 weeks |
| Change in Neurologic Functioning: Reaction Time | Reaction Time is measured using a modified Go/No-go test of inhibitory control | 0, 2, 8 weeks |
| Neurological Function (Emotional Perception) | Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT) | 0 weeks, 2 weeks, 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
| BG002 | Early Risetime Sleep Deprivation | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Early Risetime Sleep Deprivation | 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 |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms (QIDS) | Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (8 weeks) |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index | 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. | At some time points, some participants did not show up to appointments or allow a particular test to be employed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks and 8 weeks post-treatment |
|
|
|
| Secondary | Change in EEG Sleep Measures I: Total Sleep Time | 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. | Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data. | Posted | Mean | Standard Deviation | minutes | Baseline, 2 weeks, 8 weeks |
|
|
|
| Secondary | Change in EEG Sleep Measures II (Sleep Efficiency) | Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100] | Subsequent rows have lower numbers of participants analyzed due to participant flow and/or unusable data. | Posted | Mean | Standard Deviation | percent of sleep time | Baseline, 2 weeks, 8 weeks |
|
|
|
| Secondary | Change in Neuropsychological Functioning: Memory | Change in different aspects of thinking (e.g., memory, attention, executive functioning) | At some time points, some participants did not show up to appointments or allow a particular test to be employed. | Posted | Mean | Standard Deviation | words | Baseline, 2 weeks, 8 weeks |
|
|
|
| Secondary | Change in Neurologic Functioning: Reaction Time | Reaction Time is measured using a modified Go/No-go test of inhibitory control | At some time points, some participants did not show up to appointments or allow a particular test to be employed. | Posted | Mean | Standard Deviation | milliseconds | 0, 2, 8 weeks |
|
|
|
| Secondary | Neurological Function (Emotional Perception) | Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT) | At some time points, some participants did not show up to appointments or allow a particular test to be employed. | Posted | Mean | Standard Deviation | percentage of emotions accurately ID'ed | 0 weeks, 2 weeks, 8 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Late Bedtime Sleep Deprivation | 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 | 0 | 24 | 5 | 24 |
| EG002 | Early Risetime Sleep Deprivation | 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 | 0 | 25 | 0 | 25 |
|
| Mood worsening | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Week 2 |
|
|
| Week 8 |
|
|
| Week 2 |
|
|
| Week 8 |
|
|
| Week 2 |
|
|
| Week 8 |
|
|
| Week 2 |
|
|
| Week 8 |
|
|
| Week 2 |
|
|
| Week 8 |
|
|
| Week 2 |
|
|
| Week 8 |
|
|