This is a Study to Determine the Antidepressant Effects of AZD6765

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00986479
First received: September 24, 2009
Last updated: October 15, 2014
Last verified: October 2014
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Treatment Resistant Major Depressive Disorder
Interventions: Drug: AZD6765
Drug: Placebo to AZD6765

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and washout of restricted medications.

Reporting Groups
  Description
AZD6765 (150 mg) Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
Placebo Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

Participant Flow for 2 periods

Period 1:   Period 1
    AZD6765 (150 mg)     Placebo  
STARTED     12     10  
COMPLETED     10     10  
NOT COMPLETED     2     0  
Improved mood                 1                 0  
Administrative reasons                 1                 0  

Period 2:   Period 2
    AZD6765 (150 mg)     Placebo  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD6765 (150 mg)/ Placebo Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
Placebo/AZD6765 (150 mg) Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
Total Total of all reporting groups

Baseline Measures
    AZD6765 (150 mg)/ Placebo     Placebo/AZD6765 (150 mg)     Total  
Number of Participants  
[units: participants]
  12     10     22  
Age  
[units: years]
Mean ± Standard Deviation
  50.7  ± 10.9     52.4  ± 10.5     51.5  ± 10.1  
Gender  
[units: Participants]
     
Female     7     3     10  
Male     5     7     12  



  Outcome Measures
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1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

2.  Secondary:   The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

3.  Secondary:   The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

4.  Secondary:   Scale for Suicide Ideation (SSI) Total Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

5.  Secondary:   Hamilton Anxiety Rating Scale (HAM-A) Total Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

6.  Secondary:   Hamilton Depression Rating Scale-17 Item (HDRS) Total Score   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing ]

7.  Secondary:   Visual Analogue Scale (VAS) Depressed Score   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing ]

8.  Secondary:   Clinician-Administered Dissociative States Scale (CADSS) Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing ]

9.  Secondary:   Brief Psychiatric Rating Scale (BPRS) Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

10.  Secondary:   Beck Depression Inventory (BDI) Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

11.  Secondary:   Young Mania Rating Scale (YMRS) Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

12.  Secondary:   Visual Analogue Scale (VAS) Anxious Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]

13.  Secondary:   Brief Psychiatric Rating Scale (BPRS) Positive Score.   [ Time Frame: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trial Transparency
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00986479     History of Changes
Obsolete Identifiers: NCT00995111
Other Study ID Numbers: D6702C00015
Study First Received: September 24, 2009
Results First Received: October 15, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration