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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

April 29, 2008
July 9, 2010
April 2008
November 2008   (final data collection date for primary outcome measure)
CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).
To prove the principle that AZD0328 improves cognition in patients with schizophrenia as assessed as change from baseline to Day 14 in the composite score of the Groton Maze Learning Task and One Card Learning task from the CogSate test battery. [ Time Frame: baseline to Day 14 ]
Complete list of historical versions of study NCT00669903 on ClinicalTrials.gov Archive Site
  • CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).
  • CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).
  • CogState Detection Task (DT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).
  • CogState Identification Task (IT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate
  • CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
    GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate
Change from baseline to Day 14 in the CogState test battery tests of Groton Maze Learning Task, One Card Learning Task, Detection Task, Identification Task, Groton Maze Recall Task, One Back Memory Task, the International Shopping List Task. [ Time Frame: baseline to Day 14 ]
Not Provided
Not Provided
 
Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia
A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses of AZD0328 in Patients With Schizophrenia

This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: AZD0328
    Other Name: AZD0328
  • Drug: Placebo
    Other Name: Placebo
  • Experimental: 1
    AZD0328 low dose
    Intervention: Drug: AZD0328
  • Experimental: 2
    AZD0328 Optimal dose
    Intervention: Drug: AZD0328
  • Experimental: 3
    AZD0328 High dose
    Intervention: Drug: AZD0328
  • Placebo Comparator: 4
    Placebo Comparator
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
  • Low level of Extra-pyramidal symptoms
  • No clinically significant findings on physical examination

Exclusion Criteria:

  • Diagnosis of schizoaffective or schizophreniform disorders
  • Any significant psychiatric or neurological disease other than schizophrenia
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669903
D0190C00007
Not Provided
Didier Meulien - Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
July 2010

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