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-reboxetine monotherapy

Phase 2

Depressive Disorder, Major | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 28, 2021

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 Enrollment510
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00636246A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.PHASE2 COMPLETED 510 — — Jun 1, 2004Aug 1, 2005Jan 28, 202117 Estonia, Russia
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Study Endpoints
Primary Endpoints
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
visits 1-9
Secondary Endpoints
Change from Baseline in HAM-D (17-item) total score
Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
Weeks 5 and 8
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
Weeks 1, 2, 3, 5, 6, and 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sertraline/[S,S]-Reboxetine-satellite150/4EXPERIMENTAL -
Sertraline/[S,S]-Reboxetine-satellite150/6EXPERIMENTAL -
sertraline-satelliteACTIVE_COMPARATOR -
sertraline-mainACTIVE_COMPARATOR -
Sertraline/[S,S]-Reboxetine-satellite150/2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Sertraline/[S,S]-Reboxetine-mainEXPERIMENTAL -
[S,S]-reboxetine-mainACTIVE_COMPARATOR -
Interventions
NameTypeDescription
sertraline/[S,S]-reboxetineDRUGTablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks.
sertralineDRUGTablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
PlaceboDRUGTablets, orally once per day for 8 weeks
[S,S]-reboxetine monotherapyDRUGTablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version ...

Countries:EstoniaRussia
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