Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboTerminated

A phase I, multi-centre, double-blind, placebo-controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female patients fulfilling the criteria for Major Depressive Disorder

Phase I/II, randomised, double-blind, placebo-controlled study (n=60; terminated) assessing single-dose IV ketamine (Part 1) and AZD6765 (Part 2) versus placebo on BOLD pharmacoMRI signal in subjects with Major Depressive Disorder.

Target Enrollment
60 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

This multi-centre study randomised patients with DSM-IV major depressive disorder to receive a single IV infusion of ketamine (Part 1) or AZD6765 (Part 2) versus placebo to assess pharmacoMRI effects on BOLD signal in BA25 and other regions.

Secondary assessments included effects on emotional processing in amygdala and other areas, safety and pharmacodynamic/pharmacokinetic measures; follow-up visit occurred approximately 8–11 days after infusion for unresolved adverse events.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

AZD6765

experimental

Single-dose IV AZD6765 infusion (Part 2) compared to placebo for pharmacoMRI effects in MDD.

Interventions

  • Compound
    via IV• single dose

    AZD6765 IV infusion (dose not specified in registry). Part 2 of study.

Ketamine (Ketalar)

active comparator

Single-dose IV ketamine (Ketalar) infusion (Part 1) compared to placebo for pharmacoMRI effects in MDD.

Interventions

  • Ketamine
    via IV• single dose

    Ketalar (ketamine) IV infusion; concentration reported 10 mg/ml; dose not specified in registry. Part 1 of study.

Placebo

inactive

Intravenous placebo infusion.

Interventions

  • Placebo
    via IV• single dose

    Intravenous placebo infusion used as comparator.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • 1. Female or male subjects aged 18-45 years, inclusive at enrolment.
  • 2. Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the Investigator) use of a highly effective form of birth control.
  • 3. Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview (SCID) for 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent.
  • 4. Outpatient status at screening and randomisation.

Exclusion Criteria

  • 1. Subjects with a DSM IV Axis II disorder which has a major impact on the subjects current psychiatric status.
  • 2. Subjects with lifetime history of schizophrenia, bipolar, psychosis and psychotic depression.
  • 3. Subjects’ use of mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs within 14 days of Visit 2.
  • 4. Subjects with a positive urine toxicology at screening (UTS) or at Visit 2 for cocaine and/or metabolites, amphetamines, opiates, phencyclidine (PCP), and barbiturates will be excluded except for subjects testing positive for prescribed medications; subjects can be re-tested but excluded if still positive.
  • 5. OTC medicine within 48 hours prior to Visit 2 unless investigator judges it will not interfere with study procedures or safety.
  • 6. Use of any medications that could confound MRI signal per judgement of Investigator.
  • 7. Pregnancy or lactation.

Study Details

Locations

United Kingdom

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