Sleep Initiation and Maintenance DisordersPhase 4NCT00292734
STILDEP: Zolpidem in Depressive and Dysthimic Patients
A Phase 4 study testing Zolpidem in people with Sleep Initiation and Maintenance Disorders and Depression, run by Sanofi at 1 site in Hungary.
Trial summary
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- What is being tested?
- Zolpidem
- How many people
- 120 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2005to Jun 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive and dysthimic patients in acute phase of mild to moderate severity
- Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)
Who cannot join
- Regularly use of sleeping pills in the last 2-3 month
- Use of any sleeping pils in the last week
- Insufficient hepatic
- Myasthenia gravis
- Proven hypersensivity to Zolpidem
- Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
Show all 11Show fewer
- History of evidence of alcohol or drug abuse
- Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
- Abnormal snore
- Work an alternating shift
- Suffering from periodic leg movement disorder and sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.
- Being tested
- Zolpidem
- Medical subject headings
- 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.
ZolpidemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- László Erős, MD, Study director, sanofi-aventis Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292734
- Sponsor's protocol ID
- L_9259
- Other IDs
- EudraCT # : 2004-001967-24
- Status last verified
- Dec 2007
- First submitted
- 15 Feb 2006
- Last updated
- 6 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease
- ClinicalTrials.gov ID
- NCT00292734
- Acronym / sponsor ID
- L_9259
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Jun 2006
- First posted
- 16 Feb 2006 (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.
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Depressive and dysthimic patients in acute phase of mild to moderate severity
- Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)
Key exclusion criteria (11 listed)
- Regularly use of sleeping pills in the last 2-3 month
- Use of any sleeping pils in the last week
- Insufficient hepatic
- Myasthenia gravis
- Proven hypersensivity to Zolpidem
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 |
|---|---|---|
| Zolpidem | Drug | – |
Primary outcome
To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease
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 6 Dec 2007.
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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.
László Erős, MD study director
sanofi-aventis Hungary
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 Zolpidem in people with Sleep Initiation and Maintenance Disorders and Depression, run by Sanofi at 1 site in Hungary.
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 2 inclusion and 11 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 6 Dec 2007. 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 Hungary. 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?
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?
To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease. 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 6 Dec 2007.