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

This Phase I, multi-centre, double-blind, placebo-controlled parallel group study (n=60; terminated) aimed to assess the pharmacoMRI effects of AZD6765 and ketamine in male and female patients with depression (MDD).

Sponsored by AstraZeneca AB in Sweden, the study, with the protocol code D2285C00001, was prematurely ended on March 17, 2011.

The trial, conducted in the UK under MHRA, involved two investigational medicinal products (IMPs): AZD6765 and ketamine (Ketalar). The primary objective was to evaluate the impact of a single dose IV infusion of ketamine (Part 1) and AZD6765 (Part 2) compared to placebo on the Blood Oxygen Level Dependent (BOLD) signal in brain area BA25 using functional Magnetic Resonance Imaging (fMRI) in subjects with Major Depressive Disorder (MDD) aged 18-45.

The study incorporated a randomised, double-blind, placebo-controlled design, and participants were assessed for the effects of emotional processing on the BOLD signal in various brain areas. The trial involved multiple sites, lasted approximately one year, and was prematurely ended. The data monitoring committee was not engaged, and the study concluded with a follow-up visit 8-11 days after infusion.

Topic Depression
Compound Ketamine Placebo
Country Switzerland United Kingdom
Visit trial
Status Terminated
Results Published Yes
Start date 17 August 2009
End date 17 March 2011
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 60
Sex All
Age 18- 45
Therapy No

Trial Details

This prematurely ended phase I trial (n=60) sponsored by AstraZeneca AB in Sweden aimed to assess the pharmacoMRI effects of AZD6765 and ketamine in patients with Major Depressive Disorder. Conducted in the UK, the study, with the protocol code D2285C00001, utilized a randomised, double-blind, placebo-controlled design. It evaluated the impact of a single dose IV infusion of ketamine and AZD6765 on the BOLD signal in brain area BA25 using fMRI. The trial involved multiple sites, lasted approximately one year, and concluded with a follow-up visit 8-11 days after infusion.

NCT Number 2009-013110-27

Sponsors & Collaborators

AstraZeneca
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Data attribution

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