Status:
COMPLETED
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Sumitomo Pharma America, Inc.
Conditions:
Sleep Initiation and Maintenance Disorders
Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression an...
Detailed Description
Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as po...
Eligibility Criteria
Inclusion
- Score of greater than 10 on the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PRIME-MD-PHQ) telephone screen
- Diagnosis of major depressive episode based on the Structured Clinical Interview for DSM-IV (SCID)
- Score of greater than 20 on the Hamilton Rating Scale for Depression
- Meets research diagnostic criteria for insomnia disorder at least 4 nights per week
- Reported mean sleep latency greater than 30 minutes and mean sleep efficiency less than 85%
- Suitable for outpatient treatment
Exclusion
- Use of any psychotropic medications within 2 weeks of initial screening
- Bipolar disorder, schizophrenia, psychotic depression, or any other psychotic disorder
- Uncontrolled asthma or chronic obstructive pulmonary disease
- Chronic pain that may be a significant sleep-disturbing factor
- Uncontrolled thyroid disease
- Poorly controlled diabetes mellitus
- Poorly compensated congestive heart failure
- Currently taking lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep
- History of intolerance or treatment resistance to either fluoxetine or eszopiclone
- Inability to abstain from taking any psychotropics other than the study medications during the course of the protocol, including sedating antihistamines
- Use of any herbal or naturopathic treatments for sleep or mood (i.e., St. John's wort, melatonin, kava kava, valerian root, etc.)
- Currently undergoing behavioral, cognitive-behavioral, or interpersonal therapy
- Pregnant or breastfeeding
- Agrees to use an effective form of contraception for the duration of the study
- Uncontrolled symptoms of menopause, including hot flashes
- Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mm Hg, diastolic blood pressure consistently greater than 90 mm Hg)
- Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome
- Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times per week
- Reports habitual rising time later than 9 AM more than 2 times per week
- Body mass index greater than 30
- Consumes more than 3 alcoholic beverages per day
- Consumes more than 4 caffeinated beverages per day
- Habitual smoking between 11 PM and 7 AM
- Use of illicit drugs
- Score greater than 24 on the Mini Mental State Examination
- Determined to be incompetent
- Determined to be at imminent risk for suicide
- More than 5 lifetime SCID diagnoses of major depressive episodes
- More than 3 failed antidepressant trials during the current episode of depression, as determined by the Antidepressant Treatment History Form
- A course of electroconvulsive therapy during the present depressive episode
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00247624
Start Date
October 1 2005
End Date
December 1 2008
Last Update
August 28 2018
Active Locations (1)
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1
Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine
Winston-Salem, North Carolina, United States, 27157