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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: AZD0328
Drug: Placebo
Phase 2

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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD0328 low dose
Drug: AZD0328
Other Name: AZD0328
Experimental: 2
AZD0328 Optimal dose
Drug: AZD0328
Other Name: AZD0328
Experimental: 3
AZD0328 High dose
Drug: AZD0328
Other Name: AZD0328
Placebo Comparator: 4
Placebo Comparator
Drug: Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669903

Locations
United States, California
Research Center
Garden Grove, California, United States
Research Center
Glendale, California, United States
Sponsors and Collaborators
AstraZeneca
  More Information

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 22, 2014