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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: AZD6765; Drug: Placebo; Drug: Ketamine

• Registration Number: NCT01046630
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD6765	single infusion
3	Placebo	single infusion
2	Ketamine	single infusion

Primary Outcome Measures

Name	Time	Method
Measurements of BOLD signal in the brain area BA25	Day1 (at infusion)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Oxford, United Kingdom