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agomelatine

Phase 3

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 23, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment503
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00411242Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive DisorderPHASE3 COMPLETED 503 — — Dec 1, 2006 -Dec 23, 202051 United States
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Study Endpoints
Primary Endpoints
Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
8 weeks
Secondary Endpoints
To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
8 weeks
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
agomelatineDRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria * HAM-D17 total score \> or = 22 at Screening and Baseline * CGI-Severity score \> or = 4 at Screening and Baseline * Only patients who complete the core protocol are eligible to ...

Countries:United States
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