This is a Study to Determine the Antidepressant Effects of AZD6765

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 24, 2009
Last updated: January 24, 2012
Last verified: January 2012

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 2

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:

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
Drug: AZD6765
Single IV infusion of 150 mg AZD6765.
Placebo Comparator: Placebo to AZD6765 IV infusion
Drug: Placebo to AZD6765
Single IV infusion of Placebo to AZD6765


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

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 identifier: NCT00986479

United States, Maryland
Research Site
Bethesda, Maryland, United States
Sponsors and Collaborators
Principal Investigator: Carlos A Zarate,, MD National Institute of Mental Health (NIMH)
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca 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:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 21, 2014