FindTrial
Sign In

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01046630
Enrollment
128
Registered
2010-01-12
Start date
2009-12-31
Completion date
2011-03-31
Last updated
2014-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Phase I, BOLD signal, fMRI, AZD6765, BOLD signal measured by fMRI

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.

Interventions

DRUGAZD6765

single infusion

DRUGKetamine

single infusion

DRUGPlacebo

single infusion

Sponsors

University of Manchester
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Measurements of BOLD signal in the brain area BA25Day1 (at infusion)

Secondary

MeasureTime frame
Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total scoreonce 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 tasksDay2 (approx 24 post infusion)
Pharmacokinetics of AZD6765Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026