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

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ClinicalTrials.gov Identifier: NCT01046630
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : October 13, 2014
Sponsor:
Collaborators:
University of Manchester
University of Oxford
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 5, 2010
First Posted Date  ICMJE January 12, 2010
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE December 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
Measurements of BOLD signal in the brain area BA25 [ Time Frame: Day1 (at infusion) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
  • 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 ]
  • Responses on a computer based battery of behavioral tasks [ Time Frame: Day2 (approx 24 post infusion) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • Measurements of symptoms of depression using Montgomery-Åsberg 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 ]
  • Responses on a computer based battery of behavioral tasks [ Time Frame: Day2 (approx 24 post infusion) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: AZD6765
    single infusion
  • Drug: Ketamine
    single infusion
  • Drug: Placebo
    single infusion
Study Arms  ICMJE
  • Experimental: 1
    single infusion
    Intervention: Drug: AZD6765
  • Active Comparator: 2
    single infusion
    Intervention: Drug: Ketamine
  • Placebo Comparator: 3
    single infusion
    Intervention: Drug: Placebo
Publications * Downey D, Dutta A, McKie S, Dawson GR, Dourish CT, Craig K, Smith MA, McCarthy DJ, Harmer CJ, Goodwin GM, Williams S, Deakin JF. Comparing the actions of lanicemine and ketamine in depression: key role of the anterior cingulate. Eur Neuropsychopharmacol. 2016 Jun;26(6):994-1003. doi: 10.1016/j.euroneuro.2016.03.006. Epub 2016 Apr 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2011)
128
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2010)
60
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01046630
Other Study ID Numbers  ICMJE D2285C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party MSD, AstraZeneca
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Manchester
  • University of Oxford
Investigators  ICMJE
Principal Investigator: Bill Deakin, Prof University of Manchester, Neurosciance and Psychiatry Unit, UK
Principal Investigator: Guy Goodwin, Prof University of Oxford, Departmentof Psychiatry, UK
Study Director: Malene Jensen AstraZeneca R&D, Södertälje, Sweden
PRS Account AstraZeneca
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP