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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.

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Official Title

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

Study to asses pharmacodynamics, pharmacokinetics, safety and tolerability of AZD0328 in patients with schizophrenia

Research Center

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

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).

Age Continuous

Gender, Male/Female

Race, Customized

Baseline Positive and Negative Syndrome Scale (PANSS) total score. Best value for PANSS total score = 30 to worse value for PANSS total score = 210

Baseline Positive and Negative Syndrome Scale (PANSS) total score

Study Specific Characteristic

CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) standardized composite score at 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 Groton Maze Learning Task (GMLT) standardized change score at 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 One Card Learning Task (OCLT)   standardized change score at 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 Detection Task (DT) standardized change score at 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 Identification Task (IT) standardized change score at 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

CogState Groton Maze Recall Task (GMRT) standardized change score at day 14

Overall Study

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.

Arms	Assigned Interventions
Experimental: 1 AZD0328 low dose	-
Experimental: 2 AZD0328 Optimal dose	-
Experimental: 3 AZD0328 High dose	-
Placebo Comparator: 4 Placebo Comparator	-

Study to asses pharmacodynamics, pharmacokinetics, safety and tolerability of AZD0328 in patients with schizophrenia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=227&filename=CSR-D0190C00007.pdf

CSR-D0190C00007.pdf

Trial Results Summaries

Contacts

Contact