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SSR411298

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Mar 15, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment527

FDA Designations

No designations recorded

Clinical trial landscape

SSR411298 · 1 trial · 1 indication

Phase 2 1
NCT00822744An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly PatientsMajor Depressive Disorder
COMPLETED527 Analytics
PHASE2COMPLETED
An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

17-item Hamilton Depression Rating Scale (HAM-D) total score
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.

Secondary Endpoints

Montgomery-Asberg Depression Rating Scale (MADRS) total score
8 weeks (from D-1 (before randomization) up to D56)
Clinical Global Impression (CGI) scores
D-1 (before randomization) and D56
HAM-D depressed mood item score, factor scores and core item score
8 weeks (from D-1 (before randomization) up to D56)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SSR411298 10 mgEXPERIMENTALSSR411298 10 mg, one capsule once daily for 8 weeks
SSR411298 50 mgEXPERIMENTALSSR411298 50 mg, one capsule once daily for 8 weeks
SSR411298 200 mgEXPERIMENTALSSR411298 200 mg, one capsule once daily for 8 weeks
Escitalopram 10 mgACTIVE_COMPARATOREscitalopram 10 mg, one capsule once daily for 8 weeks
PlaceboPLACEBO_COMPARATORPlacebo (for SSR411298), one capsule once daily for 8 weeks

Interventions

NameTypeDescription
SSR411298DRUGForm: capsule Route: oral administration with food
EscitalopramDRUGForm: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food
Placebo (for SSR411298)DRUGForm: capsule Route: oral administration with food
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Elderly patient with recurrent Major Depressive Disorder Exclusion Criteria: * Duration of current depressive episode greater than 2 years; * Mild depression as measured by standard clinical research scales; * Cognitive disturbance; * Significant suicide risk; * Other psychi...

Countries:ChileMexicoRomaniaRussiaSlovakiaSouth AfricaUkraine
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Frequently asked questions about SSR411298

What is SSR411298 used for?

SSR411298 is an investigational small molecule being studied for the treatment of Major Depressive Disorder (MDD). It was evaluated in a Phase 2 clinical trial specifically in elderly patients aged 60 years and older. The drug is not approved and remains in clinical development.

Who makes SSR411298?

SSR411298 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi conducted a Phase 2 clinical trial of SSR411298 for Major Depressive Disorder in elderly patients.

What phase is SSR411298 in?

SSR411298 is in Phase 2 clinical development. It has completed one Phase 2 trial for Major Depressive Disorder in elderly patients. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SSR411298 in?

SSR411298 has one completed clinical trial, registered as NCT00822744. This was an eight-week, randomized, double-blind, placebo-controlled Phase 2 study evaluating SSR411298 as treatment for Major Depressive Disorder in elderly patients. The trial enrolled 527 participants across seven countries.

Is SSR411298 FDA approved?

No, SSR411298 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for Major Depressive Disorder in elderly patients. The drug remains in clinical development and has not received regulatory approval.