This is a Study to Determine the Antidepressant Effects of AZD6765 - Full Text View

Sponsor:	AstraZeneca
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00986479

Purpose

The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.

Condition	Intervention	Phase
Treatment Resistant Major Depressive Disorder	Drug: AZD6765 Drug: Placebo to AZD6765	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Suicide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of the study is to assess the efficacy of a single-intravenous infusion of AZD6765 compared to placebo. [ Time Frame: Montgomery-Asberg Depression Rating Scale (MADRS) change from baseline will be measured at pre-dose, 60, 80, 110 and 230 minutes and 24, 48 and 72 hours post-dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether AZD6765 will demonstrate a superior antidepressant efficacy compared to placebo, as assessed by the proportion of subjects in remission (defined as MADRS total score ≤10). [ Time Frame: MADRS will be assessed every day from Day 1 through Day 10 and on Day 14 ] [ Designated as safety issue: No ]
To determine whether AZD6765 will demonstrate a superior response compared to placebo, as assessed by the proportion of subjects with response (defined as a ≥50% reduction from baseline in the MADRS total score). [ Time Frame: Blood samples will be obtained on Days 1-4 and 7-11. ] [ Designated as safety issue: No ]
To evaluate the efficacy of AZD6765 in reducing suicidal ideation, as assessed by a change from baseline in the Scale for Suicide Ideation (SSI) total score. [ Time Frame: SSI will be assessed every day from Day 1 through Day 10 and on Day 14 ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	December 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD6765 IV infusion Active	Drug: AZD6765 Single IV infusion of 150 mg AZD6765.
Placebo Comparator: Placebo to AZD6765 IV infusion Placebo	Drug: Placebo to AZD6765 Single IV infusion of Placebo to AZD6765

Eligibility

Criteria

Inclusion Criteria:

Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
Females must be of non-childbearing potential.

Exclusion Criteria:

Treatment with Clozapine or ECT within 3 months prior to study
Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986479

Locations

United States, Maryland
Research Site
Bethesda, Maryland, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Carlos A Zarate,, MD

National Institute of Mental Health (NIMH)

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00986479 History of Changes
Obsolete Identifiers:	NCT00995111
Other Study ID Numbers:	D6702C00015
Study First Received:	September 24, 2009
Last Updated:	January 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Patients

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012