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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

The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.

Proof of concept study of cognitive improvement in patients with schizophrenia

D3690C00011 Clinical Study Report Synopsis

Research Site

A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study with 3 Oral Groups of AZD3480 during 12 Weeks Treatment of Cognitive Deficits in Patients with Schizophrenia

Change from Baseline to End Of Treatment (EOT) assessment, calculated as EOT value minus baseline value (baseline value is last assessment prior to start of randomized treatment) Value is measured as a z-score relative to all patient scores at baseline (ie, value=(raw score - baseline mean raw score)/(baseline SD raw score) )

Change from Baseline to End Of Treatment (EOT)assessment, calculated as EOT value minus baseline value (baseline value is last assessment prior to start of randomized treatment) Value is measured as a z-score relative to all patient scores at baseline (ie, value=(raw score - baseline mean raw score)/(baseline SD raw score) )

Change from Baseline to End Of Treatment assessment, calculated as EOT value minus baseline value (baseline value is last assessment prior to start of randomized treatment) Value is measured as a z-score relative to all patient scores at baseline (ie, value=(raw score - baseline mean raw score)/(baseline SD raw score) )

Change from Baseline to End Of Treatment (EOT)assessment, calculated as EOT value minus baseline value (baseline value is last assessment prior to start of randomized treatment). Value is sum of individual assessment items

Change from Baseline to End Of Treatment (EOT) assessment, calculated as EOT value minus baseline value (baseline value is last assessment prior to start of randomized treatment). Value is sum of individual assessment items

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: AZD3480 oral capsule
Experimental: 2 AZD3480 oral	Drug: AZD3480 oral capsule
Experimental: 3 AZD3480 oral dose	Drug: AZD3480 oral capsule

Proof of concept study of cognitive improvement in patients with schizophrenia - HALO

Official Title

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Documents available

http://www.astrazeneca.com/node/emailtriage.aspx

D3690C00011 Clinical Study Report Synopsis

Trial Results Summaries

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Principal Investigator