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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sleep scheduling
Fluoxetine
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, sleep, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

No sleep deprivation

Late bedtime sleep deprivation

Early risetime sleep deprivation

Arm Description

Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks

Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.

Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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]
Change in Neuropsychological Functioning: Memory
Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Change in Neurologic Functioning: Reaction Time
Reaction Time is measured using a modified Go/No-go test of inhibitory control
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)

Full Information

First Posted
January 12, 2012
Last Updated
January 25, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01545843
Brief Title
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Official Title
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, sleep, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No sleep deprivation
Arm Type
Active Comparator
Arm Description
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
Arm Title
Late bedtime sleep deprivation
Arm Type
Experimental
Arm Description
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
Arm Title
Early risetime sleep deprivation
Arm Type
Experimental
Arm Description
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
Intervention Type
Behavioral
Intervention Name(s)
Sleep scheduling
Intervention Description
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
20-40 mg fluoxetine daily for 8 weeks
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression-17 Item Minus Sleep Items
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)
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms (QIDS)
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)
Title
Pittsburgh Sleep Quality Index
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
Title
Change in EEG Sleep Measures I: Total Sleep Time
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
Title
Change in EEG Sleep Measures II (Sleep Efficiency)
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
Title
Change in Neuropsychological Functioning: Memory
Description
Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Time Frame
Baseline, 2 weeks, 8 weeks
Title
Change in Neurologic Functioning: Reaction Time
Description
Reaction Time is measured using a modified Go/No-go test of inhibitory control
Time Frame
0, 2, 8 weeks
Title
Neurological Function (Emotional Perception)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Todd Arnedt, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27529765
Citation
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.
Results Reference
derived

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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

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