Study Details

General Information

BMS MDD CORE 07

A Multicenter, Randomized, Double-blind, Active-Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients with Treatment Resistant Major Depression

Protocol
IdentifierCN162007
UIDbbda634f-9c76-4a33-917f-8e0221ff9710
StatusDone - Archived
Phase2b
CategoryMajor Depressive Disorder / Adult
Launch Year2011
NCT Number-
Created2011-04-06 16:37
Last Updated2011-04-06 16:37

Description

Key Elements: • The purpose of this trial is to establish the efficacy of study drug BMS-820836 compared to fixed doses of Duloxetine (Cymbalata) and Escitalopram (Lexapro). • All subjects will be receiving an active drug, but all treatment arms will receiving at least one placebo as well. • Study administration will be 4 tablets daily. • Subjects who are taking exclusionary meds can be washed out, as there is a 28 day screening window. • The study is up to 20 weeks long in duration, consisting of 17 office visits. • $45 per visit.

Comment

No comment.

Target Dates

NameDateRequired
Enrollment Closed2012-12-18No
Enrollment Open2011-09-22No
First Patient First VisitNo
Site Initiation Mtg.2011-07-29No
PI Meeting Start2011-06-23No
PI Meeting End2011-06-24No
PI Meeting ArrivalNo
PI Meeting DepartureNo
Closeout Date2013-08-08No
Final PatientVisitNo
PreStudy Selection VisitNo
Target Date 12No
Target Date 13No
Target Date 14No

Leadership

RoleStaffLoginRequired
PrincipalMohaupt, StephenSMohauptNo
Recruiter-No
CoordinatorCalleros, JessicaJNCallerosNo
RegulatoryAguirre, SandraSAguirreNo

Custom Fields

No custom fields.

Sponsor & Organization

SponsorBristol Myers Squibb
DivisionBristol Myers Squibb
TeamBristol Myers Squibb
Managing SiteCatalina Research Institute, LLC
Organization

Contacts

IRB Ref201103093
CRO
CRO RefTelephone Initiation in lieu of SIV 7/29/11
Correspondence0

Opportunity

Probability0
Comment
Status ColorGainsboro
Currency-
Mayra Sibley

2 Hours

Hi there, I'm Jesse and you?
You

3 minutes

My name is Anne Clarc.
Mayra Sibley

40 seconds

Nice to meet you Anne.
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