This is a Study to Determine the Antidepressant Effects of AZD6765

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00986479
First received: September 24, 2009
Last updated: January 24, 2012
Last verified: January 2012

September 24, 2009
January 24, 2012
December 2009
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00986479 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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). [ 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. [ Designated as safety issue: No ]
Not Provided
Not Provided
 
This is a Study to Determine the Antidepressant Effects of AZD6765
An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Treatment Resistant Major Depressive Disorder
  • Drug: AZD6765
    Single IV infusion of 150 mg AZD6765.
  • Drug: Placebo to AZD6765
    Single IV infusion of Placebo to AZD6765
  • Experimental: AZD6765 IV infusion
    Active
    Intervention: Drug: AZD6765
  • Placebo Comparator: Placebo to AZD6765 IV infusion
    Placebo
    Intervention: Drug: Placebo to AZD6765
Zarate CA Jr, Mathews D, Ibrahim L, Chaves JF, Marquardt C, Ukoh I, Jolkovsky L, Brutsche NE, Smith MA, Luckenbaugh DA. A randomized trial of a low-trapping nonselective N-methyl-D-aspartate channel blocker in major depression. Biol Psychiatry. 2013 Aug 15;74(4):257-64. doi: 10.1016/j.biopsych.2012.10.019. Epub 2012 Dec 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00986479
D6702C00015
No
AstraZeneca
AstraZeneca
National Institute of Mental Health (NIMH)
Principal Investigator: Carlos A Zarate,, MD National Institute of Mental Health (NIMH)
AstraZeneca
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP