Major Depressive DisorderPhase 3NCT00435279
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
A Phase 3 study testing Eszopiclone and Venlafaxine in people with Major Depressive Disorder and Insomnia, run by Sumitomo Pharma America, Inc. at 69 sites in 10 countries.
Trial summary
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder, Insomnia
- What is being tested?
- Eszopiclone and Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 678 participants
- Where
- 69 sitesin 10 countries
- Study dates
- Jun 2007to Jul 2009
- Phase
- Phase 3
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
- Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.
Who cannot join
- Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
- All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
- Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
Trial locations and contacts
69 sites in 10 countries.
69 sites in 10 countries
Russia12 sites
Study site
Arkhangelsk, 163001
Study site
Belchatow, 91-400
Study site
Moscow, 107076
Study site
Moscow, 115522
Study site
Moscow, 125367
Study site
Saint Petersburg, 190121
Study site
Saint Petersburg, 191180
Study site
Saint Petersburg, 192019
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 197341
Study site
Saint Petersburg, 198020
Study site
Stavropol, 355108
France11 sites
Study site
Arcachon
Study site
Caen, 14000
Study site
Élancourt, 78990
Study site
Le Pecq, 78230
Study site
Rennes, 35000
Study site
Savigny-sur-Orge
Study site
Strasbourg, 67100
Study site
Toulouse, 31000
Study site
Toulouse, 31300
Study site
Toulouse
Study site
Verasailles, 78000
Ukraine9 sites
Study site
Crimea, 95006
Study site
Dnipro, 49005
Study site
Donetsk, Pobeda District, 83037
Study site
Kiev, 02660
Study site
Kiev, 03049
Study site
Kiev, 04080
Study site
Lviv, 79021
Study site
Odesa, 65000
Study site
Vinnitsa, 21005
United Kingdom9 sites
Study site
Avon, Bath, BA 1 2SR
Study site
Coventry
Study site
Fowey, PL23 1DT
Study site
Glasgow, Scotland, G51 4TF
Study site
Glasgow, G20 OXA
Study site
Harrow, HA13UJ
Study site
Haywards Heath, RH16 4BE
Study site
Plymouth, PL6 7TH
Study site
Warks, CV32 4RA
Poland7 sites
Study site
Bełchatów, 97-400
Study site
Bydgoszcz
Study site
Krakow, 31-530
Study site
Lodz, 90-130
Study site
Lublin, 20-109
Study site
Torun, 87-100
Study site
Tuszyn, 95-080
Hungary6 sites
Study site
Balassagyarmat, 2660
Study site
Budapest, 1083
Study site
Budapest, 1134
Study site
Budapest, 1135
Study site
Cegléd, 2700
Study site
Nyíregyháza, 4412
Serbia6 sites
Study site
Belgrade, 11 000
Study site
Belgrade, 11000
Study site
Kragujevac, 34 000
Study site
Niš, 18000
Study site
Niš
Study site
Novi Sad, 21 000
Austria3 sites
Study site
Salzburg
Study site
Vienna, A-1010
Study site
Vienna, A-1090
Croatia3 sites
Study site
Split, 21 000
Study site
Zagreb, 10 000
Study site
Zagreb, 10090
Romania3 sites
Study site
Bucharest, 041902
Study site
Lasi, 700282
Study site
Oradea, 410154
About this study
Official title: A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
Read the detailed description
This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Major Depressive Disorder, Insomnia
- Being tested
- Eszopiclone, Placebo, Venlafaxine
- Keywords
- Insomnia, Depression, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Also called Lunesta
Eszopiclone 3 mg
PlaceboDrug
Placebo
VenlafaxineDrug
Also called Effexor
Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Experimental | Not described Receives: Drug: Eszopiclone; Drug: Venlafaxine |
| Placebo | Experimental | Not described Receives: Drug: Placebo; Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
Measured: Week 8
Secondary outcomes (1)
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, CNS, Study chair, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435279
- Sponsor's protocol ID
- 190-062
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2007
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia
- ClinicalTrials.gov ID
- NCT00435279
- Acronym / sponsor ID
- 190-062
- Conditions
- Major Depressive Disorder, Insomnia
- Keywords
- Insomnia, Depression, Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Feb 2007 (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.
To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
Detailed description
This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Experimental | Drug: Eszopiclone, Drug: Venlafaxine |
| Placebo | Experimental | Drug: Placebo, Drug: Venlafaxine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
- Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.
Key exclusion criteria (3 listed)
- Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
- All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major Depressive Disorder.
- Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
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: LunestaEszopiclone 3 mg | Drug | Eszopiclone |
| PlaceboPlacebo | Drug | Placebo |
| VenlafaxineAlso: EffexorVenlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28 | Drug | Eszopiclone, Placebo |
Primary outcome
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
Time frame: Week 8
1 secondary outcome
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
Time frame: Week 1
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 22 Feb 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.
Medical Director, CNS study chair
Sumitomo Pharma America, Inc.
69 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eszopiclone and Venlafaxine in people with Major Depressive Disorder and Insomnia, run by Sumitomo Pharma America, Inc. at 69 sites in 10 countries.
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 4 inclusion and 3 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Russia, France, Ukraine, United Kingdom, Poland and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. (time frame: Week 8). 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 22 Feb 2012.