Improving Sleep and Psychological Functioning in People With Depression and Insomnia

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 and insomnia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University; Wake Forest University Health Sciences
• Collaborators: National Institute of Mental Health (NIMH); Philips Healthcare; Sunovion
• Treatments: Eszopiclone; Fluoxetine; Hypnotics and Sedatives

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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