Clinical trial NCT01046630: Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Phase I
BOLD signal
fMRI
AZD6765
BOLD signal measured by fMRI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
name: University of Oxford
First posted: 2010-01-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurements of BOLD signal in the brain area BA25
timeFrame: Day1 (at infusion)
Secondary outcomes:
measure: Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score
timeFrame: 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
measure: Responses on a computer based battery of behavioral tasks
timeFrame: Day2 (approx 24 post infusion)
measure: Pharmacokinetics of AZD6765
timeFrame: Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University of Manchester, Neurosciance and Psychiatry Unit, UK
name: Bill Deakin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford, Departmentof Psychiatry, UK
name: Guy Goodwin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Malene Jensen
role: STUDY_DIRECTOR
References:
citation: Downey D, Dutta A, McKie S, Dawson GR, Dourish CT, Craig K, Smith MA, McCarthy DJ, Harmer CJ, Goodwin GM, Williams S, Deakin JF. Comparing the actions of lanicemine and ketamine in depression: key role of the anterior cingulate. Eur Neuropsychopharmacol. 2016 Jun;26(6):994-1003. doi: 10.1016/j.euroneuro.2016.03.006. Epub 2016 Apr 28.