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Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046630
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : October 13, 2014
University of Manchester
University of Oxford
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the effect of a single dose infusion of AZD 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI (functional Magnetic Resonance Imaging) in depressed subjects.

Condition or disease Intervention/treatment Phase
Depression Drug: AZD6765 Drug: Ketamine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Multi-centre, Double-blind, Placebo-controlled Parallel Group Study to Assess the pharmacoMRI Effects of AZD6765 in Male and Female Subjects Fulfilling the Criteria for Major Depressive Disorder
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
single infusion
Drug: AZD6765
single infusion

Active Comparator: 2
single infusion
Drug: Ketamine
single infusion

Placebo Comparator: 3
single infusion
Drug: Placebo
single infusion

Primary Outcome Measures :
  1. Measurements of BOLD signal in the brain area BA25 [ Time Frame: Day1 (at infusion) ]

Secondary Outcome Measures :
  1. Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score [ Time Frame: once during Day -30 to Day -1, twice Day 1 (pre and 4hrs post infusion) [BDI only pre-infusion], once Day 2 (approx 24hrs post infusion), once Day 9-12 ]
  2. Responses on a computer based battery of behavioral tasks [ Time Frame: Day2 (approx 24 post infusion) ]
  3. Pharmacokinetics of AZD6765 [ Time Frame: Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview,major depressive disorder, single episode or recurrent
  • Outpatient status at screening and at randomisation

Exclusion Criteria:

  • A major depression disorder which has a major impact on the subjects current psychiatric status
  • Subjects not allowed to use mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs
  • Subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046630

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United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
University of Manchester
University of Oxford
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Principal Investigator: Bill Deakin, Prof University of Manchester, Neurosciance and Psychiatry Unit, UK
Principal Investigator: Guy Goodwin, Prof University of Oxford, Departmentof Psychiatry, UK
Study Director: Malene Jensen AstraZeneca R&D, Södertälje, Sweden

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01046630    
Other Study ID Numbers: D2285C00001
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by AstraZeneca:
Phase I
BOLD signal
BOLD signal measured by fMRI
Additional relevant MeSH terms:
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Behavioral Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action