DepressionPhase 2NCT01545843
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
A Phase 2 study testing Sleep scheduling and Fluoxetine in people with Depression, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Sleep scheduling and Fluoxetine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years old
- Current major depressive episode
- Habitual TIB of 7 to < 10 hours
- No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)
- Score of at least 18 on the Hamilton Rating Scale of Depression
Who cannot join
- Alcohol or substance abuse/dependence in past 6 months
- Current posttraumatic stress disorder or bulimia nervosa (past 6 months)
- Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa
- Trials of fluoxetine in the past 6 months
- Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of > 5 minutes; history of seizures
- Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder
Show all 11Show fewer
- Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)
- Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).
- Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.
- Known allergy, hypersensitivity or contraindication to study medication
- Females: pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Sleep scheduling, Fluoxetine
- Keywords
- depression, sleep, treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep schedulingBehavioural
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
FluoxetineDrug
Also called Prozac
20-40 mg fluoxetine daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| No sleep deprivation | Active comparator | Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks Receives: Behavioral: Sleep scheduling; Drug: Fluoxetine |
| 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. Receives: Behavioral: Sleep scheduling; Drug: Fluoxetine |
| 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. Receives: Behavioral: Sleep scheduling; Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (8 weeks)
Secondary outcomes (7)
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.
Measured: Post-treatment (8 weeks)
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.
Measured: 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.
Measured: 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]
Measured: Baseline, 2 weeks, 8 weeks
Change in Neuropsychological Functioning: Memory
Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Measured: 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
Measured: 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)
Measured: 0 weeks, 2 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Todd Arnedt, University of Michigan
- Investigators
- J. Todd Arnedt, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545843
- Sponsor's protocol ID
- R01MH077690
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2012
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27529765
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
- ClinicalTrials.gov ID
- NCT01545843
- Acronym / sponsor ID
- R01MH077690
- Conditions
- Depression
- Keywords
- depression, sleep, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 30 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No sleep deprivation | Active comparator | Behavioral: Sleep scheduling, Drug: FluoxetineSleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks |
| Late bedtime sleep deprivation | Experimental | Behavioral: Sleep scheduling, Drug: FluoxetineSleep 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 | Behavioral: Sleep scheduling, Drug: FluoxetineSleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 and 65 years old
- Current major depressive episode
- Habitual TIB of 7 to < 10 hours
- No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)
- Score of at least 18 on the Hamilton Rating Scale of Depression
Key exclusion criteria (11 listed)
- Alcohol or substance abuse/dependence in past 6 months
- Current posttraumatic stress disorder or bulimia nervosa (past 6 months)
- Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa
- Trials of fluoxetine in the past 6 months
- Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of > 5 minutes; history of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep scheduling8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime | Behavioural | Early risetime sleep deprivation, Late bedtime sleep deprivation, No sleep deprivation |
| FluoxetineAlso: Prozac20-40 mg fluoxetine daily for 8 weeks | Drug | Early risetime sleep deprivation, Late bedtime sleep deprivation, No sleep deprivation |
Primary outcome
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
Time frame: 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.
7 secondary outcomes
Quick Inventory of Depressive Symptoms (QIDS)
Time frame: Post-treatment (8 weeks)
Pittsburgh Sleep Quality Index
Time frame: Baseline, 2 weeks and 8 weeks post-treatment
Change in EEG Sleep Measures I: Total Sleep Time
Time frame: Baseline, 2 weeks, 8 weeks
Change in EEG Sleep Measures II (Sleep Efficiency)
Time frame: Baseline, 2 weeks, 8 weeks
Change in Neuropsychological Functioning: Memory
Time frame: Baseline, 2 weeks, 8 weeks
Change in Neurologic Functioning: Reaction Time
Time frame: 0, 2, 8 weeks
Neurological Function (Emotional Perception)
Time frame: 0 weeks, 2 weeks, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27529765Arnedt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Todd Arnedt, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sleep scheduling and Fluoxetine in people with Depression, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items (time frame: Post-treatment (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.