Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Completed · Phase 4 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders, Depression

In brief

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 and insomnia.

Key facts

Study ID

NCT00247624

Run by

Wake Forest University Health Sciences

People needed

60

Starts

2005-10-01

Expected to finish

2008-12-01

Last updated by the study team

2018-08-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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