Recent Updates
Recently added Catalysts

Desvenlafaxine administered as a salt in a sustained-release form

Phase 3

Depression | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: May 7, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment381

FDA Designations

No designations recorded

Clinical trial landscape

Desvenlafaxine administered as a salt in a sustained-release form · 1 trial · 3 indications

Phase 3 1
NCT00369343Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal WomenDepression
COMPLETED381 Analytics
PHASE3COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Depression
NCT00369343381
Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
Baseline to 8 weeks

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17

Secondary Endpoints

Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
8 weeks
Percentage of Patients Achieving Remission
8 weeks
Percentage of Patients Achieving Response to Treatment
8 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)DRUGDVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
PlaceboDRUGPlacebo, daily (QD), tablet form, treatment period up to 8 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive. * A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI). * Montgomery-Asberg Depression Rating Scale ...

Countries:United States
Unlock Eligibility Criteria