Study Details

General Information

AstraZeneca MDD 031

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-controlled, Phase IIB Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants.

Protocol
IdentifierD6702C00031
UIDb6a658c9-cd01-4b5d-9f96-1d09d797a0ee
StatusDone - Archived
Phase2B
CategoryMajor Depressive Disorder / Adult
Launch Year2012
NCT Number-
Created2012-05-14 14:48
Last Updated2012-05-14 14:48

Description

Key Elements: • Male and Female patients 18 to 70 years old inclusive. • To evaluate the efficacy of AZD676165iv given intravenously in 50mg or 100mg/ infusion as adjunct to current antidepressant medication versus antidepressant medication + placebo in the treatment if patients with inadequate response to antidepressant treatment. • Patients who have exhibited an inadequate response to 3 or more different antidepressant treatment by history. One of which may include the current antidepressant medication.

Comment

No comment.

Target Dates

NameDateRequired
Enrollment Closed2012-12-05No
Enrollment Open2012-08-08No
First Patient First VisitNo
Site Initiation Mtg.2012-06-28No
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
CoordinatorCalleros, JessicaJNCallerosNo
RegulatoryAguirre, SandraSAguirreNo

Custom Fields

No custom fields.

Sponsor & Organization

SponsorAstraZeneca Pharmaceuticals
DivisionAstraZeneca Pharamecuticals
TeamAstraZeneca Pharamecuticals LP
Managing SiteCatalina Research Institute, LLC
Organization

Contacts

IRB RefIRB ID No. QUI1-11-440
CROIQVIA RDS Inc.
CRO Ref
Correspondence0

Opportunity

Probability0
Comment
Status ColorGainsboro
Currency-
Mayra Sibley

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My name is Anne Clarc.
Mayra Sibley

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