Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

NCT ID: NCT01545843

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No sleep deprivation

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

Group Type: ACTIVE_COMPARATOR

Sleep scheduling

Intervention Type: 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

Fluoxetine

Intervention Type: DRUG

20-40 mg fluoxetine daily for 8 weeks

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.

Group Type: EXPERIMENTAL

Sleep scheduling

Intervention Type: 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

Fluoxetine

Intervention Type: DRUG

20-40 mg fluoxetine daily for 8 weeks

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.

Group Type: EXPERIMENTAL

Sleep scheduling

Intervention Type: 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

Fluoxetine

Intervention Type: DRUG

20-40 mg fluoxetine daily for 8 weeks

Interventions

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

Intervention Type: BEHAVIORAL

Fluoxetine

20-40 mg fluoxetine daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Prozac

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

J. Todd Arnedt

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Todd Arnedt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27529765 (View on PubMed)

Other Identifiers

R01MH077690

Identifier Type: NIH

Identifier Source: org_study_id

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