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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01046630

Collaborator

University of Manchester (Other), University of Oxford (Other)

128

Enrollment

Locations

Arms

14.9

Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Measurements of BOLD signal in the brain area BA25 [Day1 (at infusion)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Manchester		United Kingdom
2	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