Study Details

General Information

Takeda MDD 318

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor–Induced Sexual Dysfunction.

ProtocolLu AA21004_318
IdentifierLu AA21004_318 Site Number 5028
UIDeee8877e-7db1-4a8b-be0b-2a16bb976cd8
StatusDone - Archived
Phase3b
CategoryMajor Depressive Disorder / Adult
Launch Year2011
NCT Number-
Created2011-06-13 17:00
Last Updated2011-06-13 17:00

Description

Key Elements: Study drug LuAA21004 is being compared to Escitalopram (Lexaori), Approximately 13 weeks (8 visits). $45 compensation per visit. Study drug administration: 1 tablet per day, morning, with or without food. Subject will discontinue their current SSRI at Visit 2 and for the study duration. Due to the fact the sexual dysfunction must be attributable to the SSRI use, per Dr. Mohaupt, we prefer subjects who are on not other concomitant medications and/or illnesses. However, Team Alpha can review on a case by case basis if the subject is otherwise eligible.

Comment

No comment.

Target Dates

NameDateRequired
Enrollment Closed2013-06-28No
Enrollment Open2011-09-22No
First Patient First VisitNo
Site Initiation Mtg.2011-10-07No
PI Meeting StartNo
PI Meeting EndNo
PI Meeting ArrivalNo
PI Meeting DepartureNo
Closeout Date2013-09-26No
Final PatientVisitNo
PreStudy Selection VisitNo
Target Date 12No
Target Date 13No
Target Date 14No

Leadership

RoleStaffLoginRequired
PrincipalMohaupt, StephenSMohauptNo
Recruiter-No
CoordinatorPereira, CynthiaCPereiraNo
RegulatoryAguirre, SandraSAguirreNo

Custom Fields

No custom fields.

Sponsor & Organization

SponsorTakeda
DivisionTakeda
TeamTakeda
Managing SiteCatalina Research Institute, LLC
Organization

Contacts

IRB Ref26049/17
CROIQVIA RDS Inc.
CRO Ref
Correspondence0

Opportunity

Probability0
Comment
Status ColorGainsboro
Currency-
Mayra Sibley

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