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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

This study has been completed.
Sponsor:
Collaborators:
University of Manchester
University of Oxford
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01046630
First received: January 5, 2010
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Depression
 Drug: AZD6765
Drug: Ketamine
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Measurements of BOLD signal in the brain area BA25 [ Time Frame: Day1 (at infusion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Responses on a computer based battery of behavioral tasks [ Time Frame: Day2 (approx 24 post infusion) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046630

Locations
United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
University of Manchester
University of Oxford
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01046630     History of Changes
Other Study ID Numbers: D2285C00001
Study First Received: January 5, 2010
Last Updated: December 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
BOLD signal
fMRI
AZD6765
BOLD signal measured by fMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013