NCT01046630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 5, 2010

Last Update Submit

October 10, 2014

Conditions

Depression

Keywords

Phase IBOLD signalfMRIAZD6765BOLD signal measured by fMRI

Outcome Measures

Primary Outcomes (1)

  • Measurements of BOLD signal in the brain area BA25

    Day1 (at infusion)

Secondary Outcomes (3)

  • Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score

    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

  • Responses on a computer based battery of behavioral tasks

    Day2 (approx 24 post infusion)

  • Pharmacokinetics of AZD6765

    Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion)

Study Arms (3)

1

EXPERIMENTAL

single infusion

Drug: AZD6765

2

ACTIVE COMPARATOR

single infusion

Drug: Ketamine

3

PLACEBO COMPARATOR

single infusion

Drug: Placebo

Interventions

AZD6765DRUG

single infusion

1
KetamineDRUG

single infusion

2
PlaceboDRUG

single infusion

3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Manchester, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27133029DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

AZD6765Ketamine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bill Deakin, Prof

    University of Manchester, Neurosciance and Psychiatry Unit, UK

    PRINCIPAL INVESTIGATOR

  • Guy Goodwin, Prof

    University of Oxford, Departmentof Psychiatry, UK

    PRINCIPAL INVESTIGATOR

  • Malene Jensen

    AstraZeneca R&D, Södertälje, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 12, 2010

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

GB(2)