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

NCT ID: NCT01046630

Last Updated: 2014-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

single infusion

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

single infusion

2

single infusion

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

single infusion

3

single infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single infusion

Interventions

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AZD6765

single infusion

Intervention Type DRUG

Ketamine

single infusion

Intervention Type DRUG

Placebo

single infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bill Deakin, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Manchester, Neurosciance and Psychiatry Unit, UK

Guy Goodwin, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Oxford, Departmentof Psychiatry, UK

Malene Jensen

Role: STUDY_DIRECTOR

AstraZeneca R&D, Södertälje, Sweden

Locations

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Research Site

Manchester, , United Kingdom

Site Status

Research Site

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Downey D, Dutta A, McKie S, Dawson GR, Dourish CT, Craig K, Smith MA, McCarthy DJ, Harmer CJ, Goodwin GM, Williams S, Deakin JF. Comparing the actions of lanicemine and ketamine in depression: key role of the anterior cingulate. Eur Neuropsychopharmacol. 2016 Jun;26(6):994-1003. doi: 10.1016/j.euroneuro.2016.03.006. Epub 2016 Apr 28.

Reference Type DERIVED
PMID: 27133029 (View on PubMed)

Related Links

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Other Identifiers

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D2285C00001

Identifier Type: -

Identifier Source: org_study_id

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