Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects
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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.
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
Measurements of BOLD signal in the brain area BA25 [ Time Frame: Day1 (at infusion) ]
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 ]
Responses on a computer based battery of behavioral tasks [ Time Frame: Day2 (approx 24 post infusion) ]
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) ]
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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