Depressive DisorderPhase 3ZEPHIRNCT00319709
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression
A Phase 3 study testing SR58611A in people with Depressive Disorder, run by Sanofi at 5 sites in 5 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- SR58611A
- How many people
- 288 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2006to Aug 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Outpatients or inpatients
- Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
- MADRS score equal of above 22.
Who cannot join
- Patients with a current significant risk of suicide in the investigator's clinical judgment.
- The duration of the current depressive episode is greater than 2 years.
- Patients whose current depressive episode is secondary to a general medical condition
- Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
- Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
- Patients with severe or unstable concomitant medical conditions.
Show all 12Show fewer
- History of seizures other than a single childhood febrile seizure.
- Patients with abnormal thyroid functioning.
- Patients with clinically significant ECG findings at screening.
- Patients who have taken an investigational drug in the last 3 months prior to screening.
- Any subject who has previously participated in a SR58611A protocol.
- Patients with Mini-Mental State Examination (MMSE) score < 25 at screening.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.
- Conditions
- Depressive Disorder
- Being tested
- SR58611A
- Keywords
- depression, antidepressive agents, controlled clinical trial
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR58611ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
Secondary outcomes (1)
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319709
- Sponsor's protocol ID
- EFC4846
- Other IDs
- EudraCT 2005-005597-67
- Acronym
- ZEPHIR
- Status last verified
- Mar 2009
- First submitted
- 28 Apr 2006
- Last updated
- 12 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT00319709
- Acronym / sponsor ID
- ZEPHIR / EFC4846
- Conditions
- Depressive Disorder
- Keywords
- depression, antidepressive agents, controlled clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Apr 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.
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Outpatients or inpatients
- Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
- MADRS score equal of above 22.
Key exclusion criteria (12 listed)
- Patients with a current significant risk of suicide in the investigator's clinical judgment.
- The duration of the current depressive episode is greater than 2 years.
- Patients whose current depressive episode is secondary to a general medical condition
- Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
- Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
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 |
|---|---|---|
| SR58611A | Drug | – |
Primary outcome
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
1 secondary outcome
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
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 12 Mar 2009.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR58611A in people with Depressive Disorder, run by Sanofi at 5 sites in 5 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 3 inclusion and 12 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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Bulgaria, Finland, Romania, Serbia, Slovakia. 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 outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.. 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 12 Mar 2009.