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

Ketamine

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.

Intervention / Treatment

  • AZD6765 (DRUG)
    single infusion
  • Ketamine (DRUG)
    single infusion
  • Placebo (DRUG)
    single infusion

Condition or Disease

  • Depression

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 128 (ACTUAL)
    Funded by: Industry|Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2009
    Primary Completion: Mar 01, 2011 ACTUAL
    Completion Date: Mar 01, 2011 ACTUAL
    Study First Posted: Jan 12, 2010 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 10, 2014

    Sponsors / Collaborators

    Lead Sponsor: AstraZeneca
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Oxford, England, United Kingdom
    Manchester, England, United Kingdom

    Participant Groups

    • single infusion

    • single infusion

    • single infusion

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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
    • Measurements of BOLD signal in the brain area BA25 Day1 (at infusion)
    Secondary Outcomes
    • Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score 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
    • Responses on a computer based battery of behavioral tasks Day2 (approx 24 post infusion)
    • Pharmacokinetics of AZD6765 Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion)

    More Details

    NCT Number: NCT01046630
    Other IDs: D2285C00001
    Study URL: https://clinicaltrials.gov/study/NCT01046630
    Last updated: Sep 29, 2023