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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Ketamine; Drug: Placebo; Drug: AZD6765

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01046630

D2285C00001

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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128 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

single infusion

Treatment:

Drug: AZD6765

2

Active Comparator group

Description:

single infusion

Treatment:

Drug: Ketamine

3

Placebo Comparator group

Description:

single infusion

Treatment:

Drug: Placebo