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Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Primary Purpose

Sleep Initiation and Maintenance Disorders, Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Fluoxetine
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Participants will receive treatment with eszopiclone and fluoxetine

Participants will receive treatment with placebo and fluoxetine

Outcomes

Primary Outcome Measures

Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings
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.
Relation to Self/Others (RSO) Basis-32 Subscale Ratings
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.
Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
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

Insomnia Severity Index (ISI)
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).

Full Information

First Posted
October 31, 2005
Last Updated
July 30, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH), Sumitomo Pharma America, Inc., Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00247624
Brief Title
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Official Title
Hypnotics in the Treatment of Psychiatric Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH), Sumitomo Pharma America, Inc., Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Depression
Keywords
Depression, Hypnotics, Sleep, Quality of Life, Insomnia, Suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive treatment with eszopiclone and fluoxetine
Arm Title
B
Arm Type
Active Comparator
Arm Description
Participants will receive treatment with placebo and fluoxetine
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Intervention Description
Eszopiclone 3 mg every night for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine 20 mg every morning for 9 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo every night for 8 weeks
Primary Outcome Measure Information:
Title
Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings
Description
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.
Time Frame
9 weeks
Title
Relation to Self/Others (RSO) Basis-32 Subscale Ratings
Description
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.
Time Frame
9 weeks
Title
Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
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.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Vaughn McCall, MD, MS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10733688
Citation
McCall WV, Reboussin BA, Cohen W. Subjective measurement of insomnia and quality of life in depressed inpatients. J Sleep Res. 2000 Mar;9(1):43-8. doi: 10.1046/j.1365-2869.2000.00186.x.
Results Reference
background
PubMed Identifier
10394611
Citation
Zammit GK, Weiner J, Damato N, Sillup GP, McMillan CA. Quality of life in people with insomnia. Sleep. 1999 May 1;22 Suppl 2:S379-85.
Results Reference
background
PubMed Identifier
22334811
Citation
McCall C, McCall WV. Objective vs. subjective measurements of sleep in depressed insomniacs: first night effect or reverse first night effect? J Clin Sleep Med. 2012 Feb 15;8(1):59-65. doi: 10.5664/jcsm.1664.
Results Reference
derived
PubMed Identifier
21601519
Citation
McCall WV, D'Agostino R Jr, Rosenquist PB, Kimball J, Boggs N, Lasater B, Blocker J. Dissection of the factors driving the placebo effect in hypnotic treatment of depressed insomniacs. Sleep Med. 2011 Jun;12(6):557-64. doi: 10.1016/j.sleep.2011.03.008. Epub 2011 May 20.
Results Reference
derived
PubMed Identifier
21447050
Citation
McCall C, McCall WV. Comparison of actigraphy with polysomnography and sleep logs in depressed insomniacs. J Sleep Res. 2012 Feb;21(1):122-7. doi: 10.1111/j.1365-2869.2011.00917.x. Epub 2011 Mar 29.
Results Reference
derived
PubMed Identifier
20726279
Citation
McCall WV, Blocker JN, D'Agostino R Jr, Kimball J, Boggs N, Lasater B, Haskett R, Krystal A, McDonald WM, Rosenquist PB. Treatment of insomnia in depressed insomniacs: effects on health-related quality of life, objective and self-reported sleep, and depression. J Clin Sleep Med. 2010 Aug 15;6(4):322-9.
Results Reference
derived
PubMed Identifier
20478741
Citation
McCall WV, Blocker JN, D'Agostino R Jr, Kimball J, Boggs N, Lasater B, Rosenquist PB. Insomnia severity is an indicator of suicidal ideation during a depression clinical trial. Sleep Med. 2010 Oct;11(9):822-7. doi: 10.1016/j.sleep.2010.04.004. Epub 2010 May 15.
Results Reference
derived

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Improving Sleep and Psychological Functioning in People With Depression and Insomnia

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