Major Depressive DisorderPhase 2FIDELIONCT00822744
An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
A Phase 2 study testing SSR411298 and Escitalopram in people with Major Depressive Disorder, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SSR411298 and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 527 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Dec 2008to Feb 2010
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patient with recurrent Major Depressive Disorder
Who cannot join
- Duration of current depressive episode greater than 2 years;
- Mild depression as measured by standard clinical research scales;
- Cognitive disturbance;
- Significant suicide risk;
- Other psychiatric conditions that would obscure the results of the study;
- History of failure to respond to antidepressant treatment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: An Eight-week, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Study, With Escitalopram (10 mg Daily) as Active Control, to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Doses of SSR411298 (10, 50, or 200 mg Daily) in Elderly Patients With Major Depressive Disorder
The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.
Secondary objectives are:
- To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
- To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
- To assess SSR411298 plasma concentrations.
- To assess plasma endocannabinoid concentrations.
Read the detailed description
The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.
- Conditions
- Major Depressive Disorder
- Being tested
- SSR411298, Escitalopram, Placebo (for SSR411298)
- Keywords
- Depression, Major Depressive Episode, Antidepressant
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSR411298Drug
Form: capsule
Route: oral administration with food
EscitalopramDrug
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules)
Route: oral administration with food
Placebo (for SSR411298)Drug
Form: capsule
Route: oral administration with food
| Study group | Role | What they receive |
|---|---|---|
| SSR411298 10 mg | Experimental | SSR411298 10 mg, one capsule once daily for 8 weeks Receives: Drug: SSR411298 |
| SSR411298 50 mg | Experimental | SSR411298 50 mg, one capsule once daily for 8 weeks Receives: Drug: SSR411298 |
| SSR411298 200 mg | Experimental | SSR411298 200 mg, one capsule once daily for 8 weeks Receives: Drug: SSR411298 |
| Escitalopram 10 mg | Active comparator | Escitalopram 10 mg, one capsule once daily for 8 weeks Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Placebo (for SSR411298), one capsule once daily for 8 weeks Receives: Drug: Placebo (for SSR411298) |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale (HAM-D) total score
The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively.
Measured: 8 weeks (from D-1 (before randomization) up to D56)
Secondary outcomes (8)
Montgomery-Asberg Depression Rating Scale (MADRS) total score
The MADRS consists of 10 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 6 (most severe). The minimum and maximum possible scores are 0 and 60, respectively.
Measured: 8 weeks (from D-1 (before randomization) up to D56)
Clinical Global Impression (CGI) scores
The CGI-1 Severity of Illness score is rated on a 1 to 7 point scale.
The CGI-2 Improvement score is a component of the CGI; the Improvement score captures the investigator's clinical impression regarding global improvement (or worsening) on a 7-point scale.
Measured: D-1 (before randomization) and D56
HAM-D depressed mood item score, factor scores and core item score
Measured: 8 weeks (from D-1 (before randomization) up to D56)
Geriatric Depression Scale (GDS) total score
The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients.
Measured: D-1 (before randomization) and D56
Sheehan Disability Scale (SDS) total score
The SDS contains 3 questions, which assesses interference in three domains, work and school, family life and home responsibilities, and social life. Each question is answered on a 10-point Likert Scale.
Measured: D-1 (before randomization) and D56
Hamilton Anxiety Rating scale (HAM-A) total score
The HAM-A consists of 14 items assessing signs and symptoms of anxiety. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 56 respectively.
Measured: D-1 (before randomization) and D56
Overview of Adverse Events (AE)
Measured: up to 9 weeks (from first study drug intake up to 7 days after last study drug intake)
SSR411298 plasma concentration
Plasma concentrations of SSR411298 are determined by a validated liquid chromatography tandem mass spectrometry method with a lower limit of quantification of 10 ng/mL.
Measured: predose and 3-5 hours after study drug intake on Day 21 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822744
- Sponsor's protocol ID
- DFI10560
- Other IDs
- 2008-001718-26, 2008
- Acronym
- FIDELIO
- Status last verified
- Mar 2013
- First submitted
- 13 Jan 2009
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Study, With Escitalopram (10 mg Daily) as Active Control, to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Doses of SSR411298 (10, 50, or 200 mg Daily) in Elderly Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00822744
- Acronym / sponsor ID
- FIDELIO / DFI10560
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Episode, Antidepressant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Jan 2009 (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 primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.
Secondary objectives are:
- To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
- To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
- To assess SSR411298 plasma concentrations.
- To assess plasma endocannabinoid concentrations.
Detailed description
The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SSR411298 10 mg | Experimental | Drug: SSR411298SSR411298 10 mg, one capsule once daily for 8 weeks |
| SSR411298 50 mg | Experimental | Drug: SSR411298SSR411298 50 mg, one capsule once daily for 8 weeks |
| SSR411298 200 mg | Experimental | Drug: SSR411298SSR411298 200 mg, one capsule once daily for 8 weeks |
| Escitalopram 10 mg | Active comparator | Drug: EscitalopramEscitalopram 10 mg, one capsule once daily for 8 weeks |
| Placebo | Placebo comparator | Drug: Placebo (for SSR411298)Placebo (for SSR411298), one capsule once daily for 8 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patient with recurrent Major Depressive Disorder
Key exclusion criteria (7 listed)
- Duration of current depressive episode greater than 2 years;
- Mild depression as measured by standard clinical research scales;
- Cognitive disturbance;
- Significant suicide risk;
- Other psychiatric conditions that would obscure the results of the study;
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 |
|---|---|---|
| SSR411298Form: capsule Route: oral administration with food | Drug | SSR411298 10 mg, SSR411298 200 mg, SSR411298 50 mg |
| EscitalopramForm: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food | Drug | Escitalopram 10 mg |
| Placebo (for SSR411298)Form: capsule Route: oral administration with food | Drug | Placebo |
Primary outcome
17-item Hamilton Depression Rating Scale (HAM-D) total score
Time frame: 8 weeks (from D-1 (before randomization) up to D56)
The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively.
8 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: 8 weeks (from D-1 (before randomization) up to D56)
Clinical Global Impression (CGI) scores
Time frame: D-1 (before randomization) and D56
HAM-D depressed mood item score, factor scores and core item score
Time frame: 8 weeks (from D-1 (before randomization) up to D56)
Geriatric Depression Scale (GDS) total score
Time frame: D-1 (before randomization) and D56
Sheehan Disability Scale (SDS) total score
Time frame: D-1 (before randomization) and D56
Hamilton Anxiety Rating scale (HAM-A) total score
Time frame: D-1 (before randomization) and D56
Overview of Adverse Events (AE)
Time frame: up to 9 weeks (from first study drug intake up to 7 days after last study drug intake)
SSR411298 plasma concentration
Time frame: predose and 3-5 hours after study drug intake on Day 21 and Day 56
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 15 Mar 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR411298 and Escitalopram in people with Major Depressive Disorder, run by Sanofi at 7 sites in 7 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 1 inclusion and 7 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Chile, Mexico, Romania, Russia, Slovakia and 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
17-item Hamilton Depression Rating Scale (HAM-D) total score (time frame: 8 weeks (from D-1 (before randomization) up to D56)). 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 15 Mar 2013.