AZD6765 Severe Major Depressive Disorder (MDD) IV

NCT ID: NCT00781742

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Depression Depressive Disorder MDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

100 mg iv once per dosing day

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

IV once per dosing day, multiple times during the treatment period

2

150 mg iv once per dosing day

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

IV once per dosing day, multiple times during the treatment period

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline IV once per dosing day multiple times during the treatment period

Interventions

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AZD6765

IV once per dosing day, multiple times during the treatment period

Intervention Type DRUG

Placebo

0.9% saline IV once per dosing day multiple times during the treatment period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent before any study-related procedures start.
* The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
* Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.

Exclusion Criteria

* Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
* Patient has a lifetime history of failure to ECT therapy.
* Patient is pregnant or breast feeding.
* Length of current episode of depression exceeds ≥2 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Castiglione

Role: STUDY_DIRECTOR

AstraZeneca

Gerard Sanacora

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Research Site

Little Rock, Arkansas, United States

Site Status

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Los Angeles, California, United States

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Orange, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Boca Raton, Florida, United States

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Gainsville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Overland Park, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Haverhill, Massachusetts, United States

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St Louis, Missouri, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Rochester, New York, United States

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East Stroudsburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Countries

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United States

References

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Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

Reference Type DERIVED
PMID: 34510411 (View on PubMed)

Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.

Reference Type DERIVED
PMID: 24126931 (View on PubMed)

Other Identifiers

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D6702C00009

Identifier Type: -

Identifier Source: org_study_id