Phase 4
Completed N=60
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Sleep Initiation and Maintenance Disorders · Depression
Source: ClinicalTrials.gov NCT00247624 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings — 0.81; 1.2 units on a scale
◆ Published Evidence
Highly cited
235citations · ~15 / year
Insomnia severity is an indicator of suicidal ideation during a depression clinical trial.
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.
Linked Publications (5)
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Insomnia severity is an indicator of suicidal ideation during a depression clinical trial.
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Comparison of actigraphy with polysomnography and sleep logs in depressed insomniacs.
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Treatment of insomnia in depressed insomniacs: effects on health-related quality of life, objective and self-reported sleep, and depression.
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Objective vs. subjective measurements of sleep in depressed insomniacs: first night effect or reverse first night effect?
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Dissection of the factors driving the placebo effect in hypnotic treatment of depressed insomniacs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings |
0.81; 1.2 | — |
| PRIMARY Relation to Self/Others (RSO) Basis-32 Subscale Ratings |
0.74; 1.04 | — |
| PRIMARY Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
50.2; 46.9 | — |
| SECONDARY Insomnia Severity Index (ISI) |
21.1; 20.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00247624) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.