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

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: AZD0328; Drug: Placebo

• Registration Number: NCT00669903
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-05-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2010-02-04
• Status Verified: 2010-07
• Results First Submitted QC: 2010-07-09
• Last Update Submitted: 2010-07-09
• Results First Posted: 2010-08-06
• Last Update Posted: 2010-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Diagnosis of schizoaffective or schizophreniform disorders
• Any significant psychiatric or neurological disease other than schizophrenia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AZD0328	AZD0328 Optimal dose
3	AZD0328	AZD0328 High dose
1	AZD0328	AZD0328 low dose
4	Placebo	Placebo Comparator

Primary Outcome Measures

Name	Time	Method
CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14	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

Name	Time	Method
CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14	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).
CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14	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).
CogState Detection Task (DT) Standardized Change Score at Day 14	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).
CogState Identification Task (IT) Standardized Change Score at Day 14	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
CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14	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

Trial Locations

Locations (1)

Research Center; 🇺🇸 Glendale, California, United States