This is a Study to Determine the Antidepressant Effects of AZD6765

NCT00986479 | Completed Phase 2 Results

• 1 other identifier: D6702C00015
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Treatment Resistant Major Depressive Disorder

Keywords

Patients

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

  Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.

  60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

Secondary Outcomes (12)

• The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).

  60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

• The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).

  60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

• Scale for Suicide Ideation (SSI) Total Score.

  60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

• Hamilton Anxiety Rating Scale (HAM-A) Total Score.

  60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

• Hamilton Depression Rating Scale-17 Item (HDRS) Total Score

  60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing

Study Arms (2)

AZD6765 (150 mg) / Placebo

EXPERIMENTAL

Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.

Drug: AZD6765

Placebo / AZD6765 (150 mg)

PLACEBO COMPARATOR

Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

Drug: Placebo to AZD6765

Interventions

AZD6765 DRUG

Single IV infusion of 150 mg AZD6765.

AZD6765 (150 mg) / Placebo

Placebo to AZD6765 DRUG

Single IV infusion of Placebo to AZD6765

Placebo / AZD6765 (150 mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Research Site

Bethesda, Maryland, United States

Location

Related Publications (3)

• 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.

  PMID: 34510411 DERIVED

• Lepow L, Luckenbaugh DA, Park L, Henter ID, Zarate CA Jr. Case series: Antidepressant effects of low-affinity and low-trapping NMDA receptor antagonists did not predict response to ketamine in seven subjects. J Psychiatr Res. 2017 Mar;86:55-57. doi: 10.1016/j.jpsychires.2016.10.023. Epub 2016 Nov 22. No abstract available.

  PMID: 27914292 DERIVED

• 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.

  PMID: 23206319 DERIVED

Related Links

• D6702C00015 Clinical Study Report Synopsis

MeSH Terms

Interventions

AZD6765

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Carlos A Zarate, MD

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 30, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 21, 2014
• Results First Posted: October 21, 2014

Record last verified: 2014-10

Locations

US (1)