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

• ClinicalTrials.gov Identifier: NCT00669903
• Recruitment Status: Terminated
• First Posted: May 1, 2008
• Results First Posted: August 6, 2010
• Last Update Posted: August 6, 2010
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: AZD0328; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: April 2008
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; AZD0328 low dose	Drug: AZD0328
Experimental: 2; AZD0328 Optimal dose	Drug: AZD0328
Experimental: 3; AZD0328 High dose	Drug: AZD0328
Placebo Comparator: 4; Placebo Comparator	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

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

1. CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ]
   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).
2. CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ]
   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).
3. CogState Detection Task (DT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ]
   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).
4. CogState Identification Task (IT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ]
   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
5. CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14 [ Time Frame: Baseline and Day 14 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Research Center

Garden Grove, California, United States

Research Center

Glendale, California, United States

Sponsors and Collaborators

AstraZeneca

More Information

• Responsible Party: Didier Meulien - Medical Science Director, AstraZeneca
• ClinicalTrials.gov Identifier: NCT00669903
• Other Study ID Numbers: D0190C00007
• First Posted: May 1, 2008
• Results First Posted: August 6, 2010
• Last Update Posted: August 6, 2010
• Last Verified: July 2010

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders