AZD6765 Severe Major Depressive Disorder (MDD) IV - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00781742

Purpose

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).

Condition	Intervention	Phase
Major Depressive Disorder	Drug: AZD6765 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score [ Time Frame: At every visit for 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score. [ Time Frame: Twice, at baseline and after 3 weeks.a ] [ Designated as safety issue: No ]
To evaluate the efficacy of AZD6765 in reducing suicidal ideation, as assessed by a change from baseline to Week 3 in the BSS total score. [ Time Frame: At every visit. ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs, vital signs, changes in laboratory evaluations etc. [ Time Frame: Throughout the study (ie, from randomization to week 8) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	135
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 100 mg iv once per dosing day	Drug: AZD6765 IV once per dosing day, multiple times during the treatment period
2: Experimental 150 mg iv once per dosing day	Drug: AZD6765 IV once per dosing day, multiple times during the treatment period
3: Placebo Comparator	Drug: Placebo 0.9% saline IV once per dosing day multiple times during the treatment period

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781742

Contacts

Contact: Quintiles Worldwide

clinical.studies.ns@quintiles.com

Show 27 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Michael Castiglione	AstraZeneca
Principal Investigator:	Gerard Sanacora	Yale University

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Raj Tummala, MD, Medical Science Director, Depression & Anxiety )
Study ID Numbers:	D6702C00009
Study First Received:	October 27, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00781742 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Severe depression
Depression
Depressive Disorder
MDD
Severe Major Depressive Disorder

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 01, 2009