Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Sleep Initiation and Maintenance Disorders, Depression
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Depression, Hypnotics, Sleep, Quality of Life, Insomnia, Suicide
Eligibility 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
Sites / Locations
- Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
A
B
Participants will receive treatment with eszopiclone and fluoxetine
Participants will receive treatment with placebo and fluoxetine