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Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Sleep scheduling (Behavioral); Fluoxetine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
J. Todd Arnedt, Ph.D., Principal Investigator, Affiliation: University of Michigan

Summary

The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

Clinical Details

Official title: Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hamilton Rating Scale for Depression-17 Item Minus Sleep Items

Secondary outcome:

Quick Inventory of Depressive Symptoms (QIDS)

Pittsburgh Sleep Quality Index

Change in EEG Sleep Measures

Change in Neuropsychological Functioning

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

University of Michigan, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: March 2009
Last updated: January 19, 2015

Page last updated: August 23, 2015

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