Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
1 other identifier
interventional
68
1 country
1
Brief Summary
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 depression
Started Mar 2009
Typical duration for phase_2 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
January 30, 2015
CompletedJanuary 30, 2023
January 1, 2023
3.8 years
January 12, 2012
January 13, 2015
January 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (7)
Quick Inventory of Depressive Symptoms (QIDS)
Post-treatment (8 weeks)
Pittsburgh Sleep Quality Index
Baseline, 2 weeks and 8 weeks post-treatment
Change in EEG Sleep Measures I: Total Sleep Time
Baseline, 2 weeks, 8 weeks
Change in EEG Sleep Measures II (Sleep Efficiency)
Baseline, 2 weeks, 8 weeks
Change in Neuropsychological Functioning: Memory
Baseline, 2 weeks, 8 weeks
- +2 more secondary outcomes
Study Arms (3)
No sleep deprivation
ACTIVE COMPARATORSleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
Late bedtime sleep deprivation
EXPERIMENTALSleep 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
EXPERIMENTALSleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
Interventions
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
20-40 mg fluoxetine daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 27529765DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Sample is largely young, healthy adults
Results Point of Contact
- Title
- Dr. J. Todd Arnedt
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
J. Todd Arnedt, Ph.D.
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
January 12, 2012
First Posted
March 7, 2012
Study Start
March 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 30, 2023
Results First Posted
January 30, 2015
Record last verified: 2023-01