Expired Study
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National City, California 91950


Purpose:

The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of once-a-week dosing of zicronapine, compared to daily dosing of zicronapine.


Study summary:

The study includes 2 treatment periods. The open-label, run-in, period will begin at patient enrolment into the study and continue for 3 weeks; during which all patients will receive treatment with zicronapine daily. The double-blind period will begin at patient randomization and continue for 5 weeks; during which the patients will be assigned to one group receiving treatment with zicronapine daily and 3 groups receiving once-a-week treatment with zicronapine.


Criteria:

Inclusion Criteria: - Diagnosis of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV) - A severity score of Clinical Global Impression Scale (CGI) >=4 - A total score of Positive and Negative Syndrome Scale (PANSS) >=60 - A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness) Exclusion Criteria: - Acute exacerbation which required hospitalization within the last 3 months OR required change of antipsychotic medication within the last 4 weeks - A current diagnosis or a history of substance dependence or substance abuse according to the DSM-IV-TR in the past 3 months - A significant risk of harming himself/herself or others - A positive serology for Hepatitis A, B, C, or HIV - A present condition that might compromise liver function - A medical or neurological disorder or treatment that could interfere with study treatment or compliance Other inclusion and exclusion criteria may apply.


NCT ID:

NCT01377233


Primary Contact:

Study Director
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com


Backup Contact:

N/A


Location Contact:

National City, California 91950
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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