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Completed

NCT Number: NCT01046630

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Manchester, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6765

Drug

single infusion

ketamine

Drug

single infusion

Placebo

Drug

single infusion

Primary outcomes

  1. Measurements of BOLD signal in the brain area BA25

    Time frame: Day1 (at infusion)

Secondary outcomes

  1. 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

  2. Responses on a computer based battery of behavioral tasks

    Time frame: Day2 (approx 24 post infusion)

  3. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • University of Manchester
  • University of Oxford

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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