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SSR149415

Phase 2

Anxiety Disorders | Small molecule | Psychiatry |Sanofi|Trials Updated: May 25, 2016

SSR149415 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Aug 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment968

FDA Designations

No designations recorded

SSR149415 clinical trials

SSR149415 · 3 trials · 2 indications

Phase 2 3
NCT00361491An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive DisorderDepressive Disorder
COMPLETED324 Analytics
NCT00374166An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety DisorderAnxiety Disorders
COMPLETED325 Analytics
NCT00358631An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive DisorderDepressive Disorder
COMPLETED319 Analytics
PHASE2COMPLETED
An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder
Depressive DisorderUnlock trial analytics
PHASE2COMPLETED
An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder
Anxiety DisordersUnlock trial analytics
PHASE2COMPLETED
An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder
Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score
Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.
8 weeks
The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Endpoints

The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores.
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SSR149415 - 250 mgEXPERIMENTALSSR149415 250 mg, twice daily for a maximum of 8 weeks
SSR149415 - 100 mgEXPERIMENTALSSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
ParoxetineACTIVE_COMPARATORParoxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks
PlaceboPLACEBO_COMPARATORPlacebo for a maximum of 9 weeks

Interventions

NameTypeDescription
SSR149415DRUG -
PlaceboDRUGOral administration (capsules)
ParoxetineDRUGOral administration (capsules)
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) Exclusion ...

Countries:ArgentinaBulgariaCanadaChileCroatiaMexicoRussiaUnited States
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Competitive Landscape -Anxiety Disorders 40 trials

Frequently asked questions about SSR149415

What is SSR149415 used for?

SSR149415 is an investigational small molecule being developed by Sanofi for the treatment of Depressive Disorder and Anxiety Disorders, specifically studied in patients with Major Depressive Disorder and Generalized Anxiety Disorder. It has been evaluated in Phase 2 clinical trials.

Who makes SSR149415?

SSR149415 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker SNY. The drug is an investigational small molecule in the psychiatry therapeutic area, targeting depressive and anxiety disorders.

What phase is SSR149415 in?

SSR149415 is in Phase 2 clinical development. It has completed three Phase 2 trials, two in Major Depressive Disorder and one in Generalized Anxiety Disorder. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is SSR149415 in?

SSR149415 has completed three Phase 2 trials: NCT00358631 and NCT00361491 in Major Depressive Disorder, and NCT00374166 in Generalized Anxiety Disorder. These trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 968 patients across multiple countries.

Is SSR149415 the same as any other drug?

SSR149415 is the primary identifier for this investigational compound. No alternative names have been reported in the clinical trial data, and it is distinct from other marketed psychiatric medications. It is a small molecule developed by Sanofi for depressive and anxiety disorders.