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

Study Overview
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: AZD6765
* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single infusion | Drug: AZD6765<br>* single infusion<br>|
| Active Comparator: 2<br>single infusion | Drug: Ketamine<br>* single infusion<br>|
| Placebo Comparator: 3<br>single infusion | Drug: Placebo<br>* single infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of BOLD signal in the brain area BA25 |  | Day1 (at infusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD6765, Phase I, BOLD signal, fMRI, BOLD signal measured by fMRI