Sleep Initiation and Maintenance DisordersPhase 4NCT00247624
Improving Sleep and Psychological Functioning in People With Depression and Insomnia
A Phase 4 study testing Eszopiclone and Fluoxetine in people with Sleep Initiation and Maintenance Disorders and Depression, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- What is being tested?
- Eszopiclone and Fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences; Department of Psychiatry and Behavioral Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Hypnotics in the Treatment of Psychiatric Disorders
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.
Read the 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.
- Being tested
- Eszopiclone, Fluoxetine, Placebo
- Keywords
- Depression, Hypnotics, Sleep, Quality of Life, Insomnia, Suicide
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Eszopiclone 3 mg every night for 8 weeks
FluoxetineDrug
Fluoxetine 20 mg every morning for 9 weeks
PlaceboDrug
Placebo every night for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive treatment with eszopiclone and fluoxetine Receives: Drug: Eszopiclone; Drug: Fluoxetine |
| B | Active comparator | Participants will receive treatment with placebo and fluoxetine Receives: Drug: Fluoxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 9 weeks
Secondary outcomes (1)
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).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Sumitomo Pharma America, Inc., Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- W. Vaughn McCall, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247624
- Sponsor's protocol ID
- R34MH070821
- Other IDs
- DSIR 83-ATSO, R34MH070821
- Status last verified
- Jul 2018
- First submitted
- 31 Oct 2005
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 10733688Zammit 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.
PubMed 10394611McCall 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.
PubMed 22334811McCall 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.
PubMed 21601519McCall 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.
PubMed 21447050McCall 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.
PubMed 20726279McCall 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.
PubMed 20478741
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotics in the Treatment of Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT00247624
- Acronym / sponsor ID
- R34MH070821
- Keywords
- Depression, Hypnotics, Sleep, Quality of Life, Insomnia, Suicide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Sumitomo Pharma America, Inc., Philips Healthcare
- Study start
- Oct 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Eszopiclone, Drug: FluoxetineParticipants will receive treatment with eszopiclone and fluoxetine |
| B | Active comparator | Drug: Fluoxetine, Drug: PlaceboParticipants will receive treatment with placebo and fluoxetine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EszopicloneEszopiclone 3 mg every night for 8 weeks | Drug | A |
| FluoxetineFluoxetine 20 mg every morning for 9 weeks | Drug | A, B |
| PlaceboPlacebo every night for 8 weeks | Drug | B |
Primary outcome
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.
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.
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.
1 secondary outcome
Insomnia Severity Index (ISI)
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10733688McCall 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.
- Background: PubMed 10394611Zammit 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.
- Derived from this study: PubMed 22334811McCall 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.
- Derived from this study: PubMed 21601519McCall 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.
- Derived from this study: PubMed 21447050McCall 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.
- Derived from this study: PubMed 20726279McCall 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.
- Derived from this study: PubMed 20478741McCall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Vaughn McCall, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone and Fluoxetine in people with Sleep Initiation and Maintenance Disorders and Depression, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings (time frame: 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247624, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.