Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Depression Clinical Trial

Official title:

Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545843
• Other study ID #: R01MH077690
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Post-treatment (8 weeks)
Secondary	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.	Baseline, 2 weeks and 8 weeks post-treatment
Secondary	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.	Baseline, 2 weeks, 8 weeks
Secondary	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]	Baseline, 2 weeks, 8 weeks
Secondary	Change in Neuropsychological Functioning: Memory	Change in different aspects of thinking (e.g., memory, attention, executive functioning)	Baseline, 2 weeks, 8 weeks
Secondary	Change in Neurologic Functioning: Reaction Time	Reaction Time is measured using a modified Go/No-go test of inhibitory control	0, 2, 8 weeks
Secondary	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)	0 weeks, 2 weeks, 8 weeks