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Improving Sleep and Psychological Functioning in People With Depression and Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247624
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : December 13, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Sunovion
Philips Healthcare
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Depression Drug: Eszopiclone Drug: Fluoxetine Drug: Placebo Phase 4

Detailed Description:

Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as poor quality of life and increased risk of suicide. Studies have shown that treating insomnia during a major depressive episode may not only help reduce symptoms of major depression during the day, but also improve an individual's general quality of life. Thus, sleeping pills, also known as hypnotics, are commonly prescribed for people with psychiatric disorders. However, little is known about the safety and efficacy of combining sleeping pills with antidepressant medications. 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.

Participants in this double-blind study will first receive fluoxetine, an antidepressant medication, for 1 week. Participants whose symptoms of insomnia subside after this initial week will continue on fluoxetine for the duration of the study and will not receive sleeping pills. Those who do not experience an improvement in their symptoms of insomnia after 1 week will be randomly assigned to receive either placebo or eszopiclone, which is a sleeping pill, in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend study visits at various points throughout the treatment phase. Follow up visits will occur periodically over the next 4 months. Assessments will include physiological measures during sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of movement during sleep.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypnotics in the Treatment of Psychiatric Disorders
Study Start Date : October 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Participants will receive treatment with eszopiclone and fluoxetine
Drug: Eszopiclone
Eszopiclone 3 mg every night for 8 weeks

Drug: Fluoxetine
Fluoxetine 20 mg every morning for 9 weeks

Active Comparator: B
Participants will receive treatment with placebo and fluoxetine
Drug: Fluoxetine
Fluoxetine 20 mg every morning for 9 weeks

Drug: Placebo
Placebo every night for 8 weeks




Primary Outcome Measures :
  1. Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings [ Time Frame: 9 weeks ]
    The BASIS 32 psychometric includes several subscales, including "daily living and role functioning" (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

  2. Relation to Self/Others (RSO) Basis-32 Subscale Ratings [ Time Frame: 9 weeks ]
    The BASIS 32 psychometric includes several subscales, including "relation to self and others" (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

  3. Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 9 weeks ]
    The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks.


Secondary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 9 weeks ]
    The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247624


Locations
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United States, North Carolina
Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Mental Health (NIMH)
Sunovion
Philips Healthcare
Investigators
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Principal Investigator: W. Vaughn McCall, MD, MS Wake Forest University Health Sciences

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00247624    
Other Study ID Numbers: R34MH070821 ( U.S. NIH Grant/Contract )
DSIR 83-ATSO
R34MH070821 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2005    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: August 28, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Depression
Hypnotics
Sleep
Quality of Life
Insomnia
Suicide
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hypnotics and Sedatives
Eszopiclone
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Central Nervous System Depressants