Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Intervention: Eszopiclone; Fluoxetine; Placebo
Intervention description: Eszopiclone 3 mg every night for 8 weeks; Fluoxetine 20 mg every morning for 9 weeks; Placebo every night for 8 weeks
Intervention MeSH terms: Eszopiclone; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Depression; Hypnotics; Sleep; Quality of Life; Insomnia; Suicide

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.
    

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