Study Details

General Information

Lilly MDD H9P-MC-LNBR

A Randomized Placebo-Controlled, Double-Blind Study of (study drug)Flexible-Dose 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

ProtocolH9P-MC-LNBR
IdentifierH9P-MC-LNBR
UID81a77603-0a50-4324-8cb5-e84d98bc3a3a
StatusDone - Archived
Phase3
CategoryMajor Depressive Disorder / Adult
Launch Year2011
NCT Number-
Created2010-12-10 13:08
Last Updated2010-12-10 13:08

Description

Key Elements: • Study drug LY2216684 is being studies as adjunct therapy in patients who are partially responding to SSRIs and may still be experiencing sleep disturbance, fatigues, loss of interest, and difficulty concentrating. • Patients will continue on their current SSRI treatment throughout the study. • Pharmacy card will be provided at Visit 2/Randomization to help pay for their current SSRI treatment throughout the trial. • 13 Weekly visits (including Safer Interview) • $45 per visit • Patients will meet with Dr. Martinez or Dr. Mohaupt at every visit.

Comment

No comment.

Target Dates

NameDateRequired
Enrollment Closed2012-03-23No
Enrollment Open2011-03-11No
First Patient First VisitNo
Site Initiation Mtg.2011-02-17No
PI Meeting Start2011-01-14No
PI Meeting End2011-01-15No
PI Meeting ArrivalNo
PI Meeting DepartureNo
Closeout Date2013-01-28No
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

SponsorEli Lilly and Company
DivisionLilly
TeamLilly
Managing SiteCatalina Research Institute, LLC
Organization

Contacts

IRB RefIRB ID No. 25604/15
CROICON Clinical Research, LLC
CRO Ref
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.
How can i help you?