Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia

This study has been terminated.
(Since AZD0328 is unlikely to meet the current Target Product Profile, Astrazeneca decided to stop further development of AZD0328)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00669903
First received: April 29, 2008
Last updated: July 9, 2010
Last verified: July 2010
Results First Received: February 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: AZD0328
Drug: Placebo

  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 two US centers were inititated with first patient enrolled on 2 April 2008 and last patient completed on 4 November 2008. A total of 158 patients were enrolled with 100 patients allocated to randomized treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were to receive a stable dose of an antipsychotic for the 4 weeks prior to randomization, have stable psychotic symptoms without a hospitalization for the 8 weeks prior to randomization, and were to be smoking an average of >=10 cigarettes per day. Enrolled patients who no longer met entry criteria at randomization were not randomized.

Reporting Groups
  Description
AZD0328 Low Dose Group AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
AZD0328 Optimal Dose Group AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
AZD0328 High Dose Group AZD0328 High dose group (0.075 to 0.675 mg oral solution)
Placebo Placebo

Participant Flow:   Overall Study
    AZD0328 Low Dose Group     AZD0328 Optimal Dose Group     AZD0328 High Dose Group     Placebo  
STARTED     23     37     18     22  
Completed Treatment Period     23     33     13     19  
COMPLETED     22     32     13     18  
NOT COMPLETED     1     5     5     4  
Adverse Event                 0                 1                 3                 1  
Withdrawal by Subject                 0                 2                 2                 2  
Lost to Follow-up                 1                 1                 0                 1  
Protocol Violation                 0                 1                 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
AZD0328 Low Dose Group AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
AZD0328 Optimal Dose Group AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
AZD0328 High Dose Group AZD0328 High dose group (0.075 to 0.675 mg oral solution)
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    AZD0328 Low Dose Group     AZD0328 Optimal Dose Group     AZD0328 High Dose Group     Placebo     Total  
Number of Participants  
[units: participants]
  23     37     18     22     100  
Age  
[units: Years]
Mean ± Standard Deviation
  38.5  ± 11.2     41.7  ± 9.2     38.3  ± 9.8     40.0  ± 9.8     40.0  ± 9.9  
Gender  
[units: Participants]
         
Female     1     4     3     2     10  
Male     22     33     15     20     90  
Race/Ethnicity, Customized  
[units: Participants]
         
Caucasian     4     3     1     2     10  
Black     18     33     17     18     86  
Other     1     1     0     2     4  
Baseline Positive and Negative Syndrome Scale (PANSS) total score [1]
[units: Points of PANSS score]
Mean ± Standard Deviation
  67.9  ± 10.3     71.8  ± 12.0     72.1  ± 12.2     69.5  ± 13.2     70.4  ± 11.9  
[1] Baseline Positive and Negative Syndrome Scale (PANSS) total score. Best value for PANSS total score = 30 to worse value for PANSS total score = 210



  Outcome Measures
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1.  Primary:   CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14   [ Time Frame: Baseline and Day 14 ]

2.  Secondary:   CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14   [ Time Frame: Baseline and Day 14 ]

3.  Secondary:   CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14   [ Time Frame: Baseline and Day 14 ]

4.  Secondary:   CogState Detection Task (DT) Standardized Change Score at Day 14   [ Time Frame: Baseline and Day 14 ]

5.  Secondary:   CogState Identification Task (IT) Standardized Change Score at Day 14   [ Time Frame: Baseline and Day 14 ]

6.  Secondary:   CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14   [ Time Frame: Baseline and Day 14 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Didier Meulien - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00669903     History of Changes
Other Study ID Numbers: D0190C00007
Study First Received: April 29, 2008
Results First Received: February 4, 2010
Last Updated: July 9, 2010
Health Authority: United States: Food and Drug Administration