Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

January 25, 2023 updated by: J. Todd Arnedt, University of Michigan
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No sleep deprivation
Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks
Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Names:
  • Prozac
Experimental: Late bedtime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Names:
  • Prozac
Experimental: Early risetime sleep deprivation
Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
Behavioral: Sleep scheduling
8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
Drug: Fluoxetine
20-40 mg fluoxetine daily for 8 weeks
Other Names:
  • Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Inventory of Depressive Symptoms (QIDS)
Time Frame: Post-treatment (8 weeks)
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
Time Frame: Baseline, 2 weeks and 8 weeks post-treatment
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
Time Frame: Baseline, 2 weeks, 8 weeks
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)
Time Frame: Baseline, 2 weeks, 8 weeks
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
Time Frame: Baseline, 2 weeks, 8 weeks
Change in different aspects of thinking (e.g., memory, attention, executive functioning)
Baseline, 2 weeks, 8 weeks
Change in Neurologic Functioning: Reaction Time
Time Frame: 0, 2, 8 weeks
Reaction Time is measured using a modified Go/No-go test of inhibitory control
0, 2, 8 weeks
Neurological Function (Emotional Perception)
Time Frame: 0 weeks, 2 weeks, 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: J. Todd Arnedt, Ph.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH077690 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Sleep scheduling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe