Clinical TrialDepressive DisordersPlaceboKetaminePlaceboCompleted

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

Randomised, Phase I fMRI study (n=128) comparing a single infusion of AZD6765, ketamine, and placebo in adults with depression to assess BOLD fMRI responses.

Target Enrollment
128 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This randomized study compares the pharmacological effects of a single infusion of AZD6765 versus ketamine and placebo on BOLD signal measured with fMRI in adults with major depressive disorder.

Primary purpose is basic science; three single-infusion arms (AZD6765, ketamine, placebo). Outcomes include fMRI BOLD responses and safety/tolerability measures; sites in Manchester and Oxford, UK.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

AZD6765

experimental

Single infusion of investigational NMDA antagonist (AZD6765).

Interventions

  • Placebo
    via IV• single dose

    AZD6765 single infusion (dose not specified in registry); experimental agent recorded as AZD6765.

Ketamine

active comparator

Single infusion of ketamine comparator.

Interventions

  • Ketamine
    via IV• single dose

    Single infusion of ketamine (dose not specified in registry).

Placebo

inactive

Single placebo infusion.

Interventions

  • Placebo
    via IV• single dose

    Placebo infusion.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion 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

  • 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 Details

Locations

Research Site — Manchester, United Kingdom
Research Site — Oxford, United Kingdom

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