InsomniaPhase 4NCT00813735
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
A Phase 4 study testing Eszopiclone and Escitalopram in people with Insomnia, run by Lehigh Center for Clinical Research at 1 site in United States.
Trial summary
Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Eszopiclone and Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline
Who cannot join
- May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
About this study
Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.
- Conditions
- Insomnia
- Being tested
- Eszopiclone, Placebo, Escitalopram
- Keywords
- Insomnia, Major Depression, Geriatric
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Also called Escitalopram 10mg or 20mg daily in the AM
Eszopiclone 2mg daily at bedtime
PlaceboDrug
Also called Escitalopram 10mg or 20mg daily in the AM
Placebo daily at bedtime
EscitalopramDrug
Escitalopram 10mg or 20mg
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Experimental | Drug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg Receives: Drug: Eszopiclone; Drug: Escitalopram |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Escitalopram 10mg or 20mg Receives: Drug: Placebo; Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep time from baseline to final visit
Measured: from baseline to final visit
Secondary outcomes (6)
change in sleep latency from baseline to final visit
Measured: from baseline to final visit
Change in HAMD from baseline to final visit
Measured: from baseline to final visit
Change in ISI from baseline to final visit
Measured: baseline to final visit
Change in CGI-S, CGI-I from baseline to final visit
Measured: baseline to final visit
labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height
Measured: visit 1
vitals: BP,pulse,temperature,weight,assess AE's/SAE's
Measured: every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startSep 2006
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Center for Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul K Gross, Principal investigator, Lehigh Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813735
- Sponsor's protocol ID
- ESRCO66
- Status last verified
- Oct 2012
- First submitted
- 22 Dec 2008
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00813735
- Acronym / sponsor ID
- ESRCO66
- Conditions
- Insomnia
- Keywords
- Insomnia, Major Depression, Geriatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lehigh Center for Clinical ResearchUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Sep 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.
Detailed description
This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Experimental | Drug: Eszopiclone, Drug: EscitalopramDrug: Eszopiclone 2mg, Drug: Escitalopram 10mg or 20mg |
| Placebo | Placebo comparator | Drug: Placebo, Drug: EscitalopramDrug: Placebo, Drug: Escitalopram 10mg or 20mg |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline
Key exclusion criteria (1 listed)
- May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries
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 |
|---|---|---|
| EszopicloneAlso: Escitalopram 10mg or 20mg daily in the AMEszopiclone 2mg daily at bedtime | Drug | Eszopiclone |
| PlaceboAlso: Escitalopram 10mg or 20mg daily in the AMPlacebo daily at bedtime | Drug | Placebo |
| EscitalopramEscitalopram 10mg or 20mg | Drug | Eszopiclone, Placebo |
Primary outcome
Change in total sleep time from baseline to final visit
Time frame: from baseline to final visit
6 secondary outcomes
change in sleep latency from baseline to final visit
Time frame: from baseline to final visit
Change in HAMD from baseline to final visit
Time frame: from baseline to final visit
Change in ISI from baseline to final visit
Time frame: baseline to final visit
Change in CGI-S, CGI-I from baseline to final visit
Time frame: baseline to final visit
labs (CBC,urinalysis,TSH,Chemprofile,drugscreen),height
Time frame: visit 1
vitals: BP,pulse,temperature,weight,assess AE's/SAE's
Time frame: every visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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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.
Paul K Gross principal investigator
Lehigh Center for Clinical Research
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 Escitalopram in people with Insomnia, run by Lehigh Center for Clinical Research 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 1 inclusion and 1 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 3 Oct 2012. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in total sleep time from baseline to final visit (time frame: from baseline to final visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2012.